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SEC Company Response from MYRIAD GENETICS INC (MYGN) (CIK 0000899923) (MYGN) — Mar 12, 2008

MYRIAD GENETICS INC (MYGN) (CIK 0000899923)
Date: March 12, 2008 · CIK: 0000899923 · Accession: 0001193125-08-054132

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Referenced dates: February 27, 2008

Date
March 12, 2008
Author
Not clearly detected
Form
CORRESP
Company
MYRIAD GENETICS INC (MYGN) (CIK 0000899923)

Letter

Correspondence

Scott A. Samuels | 617 348 1798 | ssamuels@mintz.com

One Financial Center

Boston, MA 02111

617-542-6000

617-542-2241 fax

www.mintz.com

March 12, 2008

VIA EDGAR AND OVERNIGHT MAIL

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attn: James Rosenberg

Senior Assistant Chief Accountant

Mail Stop 6010

Re: Myriad Genetics, Inc.

Form 10-K for Fiscal Year Ended June 30, 2007

File No. 0-26642

Ladies and Gentlemen:

On behalf of our client Myriad Genetics, Inc., a Delaware corporation (the “Company”), submitted herewith is the Company’s response to comments contained in the letter dated February 27, 2008, from Mr. James Rosenberg, Senior Assistant Chief Accountant, of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) to Mr. Peter D. Meldrum, President and Chief Executive Officer of the Company, concerning the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2007 (the “2007 Annual Report”). The 2007 Annual Report was filed with the Commission on August 29, 2007.

The comments and responses set forth below are keyed to the numbering of the comments and the headings used in the Staff’s letter and are based upon information provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by the Company. Unless otherwise stated, all references to “Myriad,” “we,” “us,” “our,” the “Company” and similar designations refer to Myriad Genetics, Inc. and its subsidiaries.

Form 10-K for the fiscal year ended June 30, 2007

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview, page 31

Comment:

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

BOSTON | WASHINGTON | NEW YORK | STAMFORD | LOS ANGELES | PALO ALTO | SAN DIEGO | LONDON

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

March 12, 2008

Page

1. You do not appear to separately quantify costs incurred for your five product candidates or provide sufficient information that would allow investors to determine the reasonably likely timing for your product commercialization and related revenue generation. Please revise your disclosure to provide the following information for each of these research and development projects. Refer to the Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address:

http://www.sec.gov/divisions/corpfin/cfcrg032001.htm#secviii.

a. The costs incurred during each period presented and to date on the project;

b. The nature, timing and estimated costs of the efforts necessary to complete the project;

c. The anticipated completion date for the project;

d. The risks and uncertainties associated with completing development or schedule, and the consequences to operations, financial position and liquidity if the project is not completed timely; and

e. The period in which material net cash inflows from the project are expected to commence.

Regarding a. if you do not maintain any research and development costs by project, disclose why management does not maintain and evaluate research and development costs by project. Provide other quantitative or qualitative disclosure that indicates the amount of the company’s resources being used on the project.

Regarding b. and c. disclose the amount or range of estimated costs and timing to complete the phase in process and each future phase. To the extent that information is not estimable, disclose those facts and circumstances indicating the uncertainties that preclude you from making a reasonable estimate.

Response:

Costs Incurred During Each Period and to Date on Each Project: Currently, the only research and development costs we track by individual drug candidate are external costs such as services provided to us by clinical research organizations, manufacturing of drug supply and other outsourced research. In order to efficiently utilize resources, internal research costs of our drug candidates are managed on a consolidated basis. Due to this fact, we do not track or assign to individual drug candidates internal costs of research and development such as salaries and benefits, facilities costs, lab supplies, and the costs of preclinical research and studies. The mix of internal and external costs varies by drug candidate. Because of this distinction and our inability to report internal costs, we believe that disclosure of only our external costs would provide an incomplete picture of the research and development costs of each of our drug candidates and would be misleading to investors.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

March 12, 2008

Page

In addition, we believe that disclosure of the external portion of our research and development costs for each drug candidate would result in serious competitive harm to us. Discussions with potential business partners, contract negotiations for pricing with potential customers, and our position relative to competitors with similar drug candidates could be negatively impacted by public disclosure of this information.

As disclosed in our 2007 Annual Report on page 8, we are competing against some of the largest pharmaceutical and biotechnology companies in the world. Many of these competitors are not obligated to disclose the costs of their research and development of competing products due to the lack of materiality of such projects as compared to other research and development projects on which they are engaged, or due to the lack of materiality of such projects in relation to their financial statements taken as a whole. The specific and detailed disclosure of research and development costs incurred by us, as requested, especially in light of the lack of equivalent disclosure by many of our competitors, would place us at an unfair competitive disadvantage. Such information would weaken our competitive position in that a competitor would be armed with commercially sensitive information about us that would enable the competitor to alter or accelerate its competitive program in response to our historic level of expenditures or recent changes in our level of expenditures in its programs.

Furthermore, we believe that disclosure of such information would place us at a competitive disadvantage in negotiating with vendors and service providers, including third-party clinical research organizations, and potential strategic collaborators. If these parties became aware of the amount of research and development expenditures allocated to a given project as compared to our aggregate research and development costs for a particular period, they would be in a position of leverage in negotiating the terms for the services they provide or the terms of a proposed collaboration, as the case may be, which could negatively impact our ability to secure agreements with them on optimal terms, or could even make certain proposed arrangements commercially prohibitive to us.

For these reasons, we believe that disclosure of this proprietary information would cause us serious competitive harm. Accordingly, we respectfully propose that we be allowed to continue reporting research and development costs on an aggregate basis.

Nature, Timing and Estimated Costs to Complete Each Project/Anticipated Completion Date/ Risks and Uncertainties Associated with Completion of each Project /Period in Which Material Cash Inflows are Expected: We respectfully submit that it is not practicable for us to disclose with reasonable accuracy the nature, timing and estimated costs to complete each of our research and development projects, other than the nature and timing of our lead product candidate, Flurizan, which is in Phase 3 clinical trials. Our next most advanced product candidate is in Phase 2 clinical trials, while all of our

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

March 12, 2008

Page

other product candidates are in Phase 1 clinical trials. Accordingly, given the early stage of development of our pipeline products and the uncertainty inherent in the drug development and regulatory process, we are unable to ascertain or estimate with any reasonable degree of accuracy or certainty the information requested. The successful development of any drug candidate, including those that we currently have under development, is inherently uncertain. The process of researching, developing, manufacturing, testing and bringing to market a new drug candidate takes many years. The duration of a project is dependent upon, among other things, the type, complexity and novelty of the product and requires the expenditure of substantial resources.

Clinical development of new drugs in the United States is a lengthy and uncertain process that includes several steps regulated by the FDA. Preclinical research and development is followed by the filing of an Investigational New Drug Application (“IND”) with the FDA that, if successful, allows clinical studies of the potential new drug to commence. Clinical development typically involves three phases of study: Phase I, II and III. Each phase typically takes longer to complete and is more costly than the preceding phase, with the most significant costs associated with clinical development incurred during Phase III trials, as they tend to be the longest and largest studies conducted during the drug development process. Importantly, the actual cost and timing of a clinical trial are dependent upon a number of factors which are not determinable until the trial is designed and/or has commenced. In addition, even after a clinical trial has been designed and commenced, there can be unanticipated delays and costs involved with such trial. For example, the rate of completion of a trial depends upon, among other things, the rate of patient enrollment, which is itself dependent upon factors such as the size of the patient population and the proximity of patients to the trial sites, the nature of the clinical protocol and the eligibility criteria for the trial. Furthermore, the FDA may alter, suspend or even terminate clinical trials at any time. Projects that have been progressing well may be discontinued abruptly due to negative results of current tests or trials. Conversely, additional trials may be designed or commenced due to positive results of current tests or trials.

In addition, estimating the period in which material cash inflows are expected and the amount of such cash flows, if any, is influenced by additional factors such as estimating market size, competition at the time of entry into the market, and efforts required to build the marketing infrastructure and sales force necessary to successfully launch the product at points in time that may be years into the future.

Therefore, it is difficult, if not impossible, to predict with any degree of accuracy, especially at the early stages of drug development, (i) the nature, timing and estimated costs to complete each project, (ii) the anticipated completion date of each project, (iii) the risks and uncertainties associated with completion of each project, or (iv) when material cash inflows are expected. We respectfully submit that to be required to provide such information, other than the suggested disclosure below, would place the Company either in the position of furnishing information which is potentially misleading, or information so qualified as to its accuracy as to be of little value to investors.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

March 12, 2008

Page

Proposed Disclosure in Future Filings: In response to this comment, we propose that our MD&A disclosure be revised in all future filings by the Company under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), where such disclosure is applicable, and to be updated as circumstances dictate, as follows:

Our research and development expenses include costs incurred for our drug candidates currently in human clinical trials, including Flurizan, Azixa, Vivecon, MPC-0920, and MPC-2130. Currently, the only costs we track by each drug candidate are external costs such as services provided to us by clinical research organizations, manufacturing of drug supply, and other outsourced research by individual drug candidate. We do not assign to each drug candidate our internal costs such as salaries and benefits, facilities costs, lab supplies and the costs of preclinical research and studies. All research and development costs for our drug candidates are expensed as incurred.

Our lead drug candidate, Flurizan, comprises the majority of our research and development costs for our clinical drug candidates. Based on our current estimates, we anticipate our U.S. Phase 3 trial of Flurizan will be completed in mid-2008, and that development costs associated with a follow-on open label study will continue until we obtain regulatory approval from the FDA, if at all. We anticipate our European Phase 3 trial of Flurizan will be completed in late 2008, and that development costs associated with this trial will end shortly thereafter. Any future revenue and cash flow from potential sales of Flurizan are subject to a number of factors, including results from our ongoing clinical trials, regulatory approval, market acceptance of our product, and other factors. If we are able to successfully commercialize Flurizan, we anticipate revenues and cash flows from sales of this product to commence sometime in mid- to late-2009.

The timing and amount of any future expenses, completion dates, and revenues for our other drug candidates is not readily determinable due to the early stage of development of those candidates.

We do not know if we will be successful in developing any of our drug candidates. While expenses associated with the completion of our current clinical programs are expected to be substantial and increase, we believe that accurately projecting total program-specific expenses through commercialization is not possible at this time. The timing and amount of these expenses will depend upon the costs associated with potential future clinical trials of our drug candidates, and the related expansion of our research and development organization, regulatory requirements, advancement of our preclinical programs and product manufacturing costs, many of which cannot be determined with accuracy at this time. We are also unable to predict when, if ever,

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

March 12, 2008

Page

material net cash inflows will commence from our drug candidates other than Flurizan. This is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of unanticipated events arising during clinical development, including:

•

the scope, rate of progress, and expense of our clinical trials and other research and development activities;

•

the length of time required to enroll suitable subjects;

•

the number of subjects that ultimately participate in the trials;

•

the efficacy and safety results of our clinical trials and the number of additional required clinical trials;

•

the terms and timing of regulatory approvals;

•

our ability to market, commercialize and achieve market acceptance for our product candidates that we are developing or may develop in the future; and

•

the filing, prosecuting, defending or enforcing any patent claims or other intellectual property rights.

A change in the outcome of any of the foregoing variables in the development of a drug candidate could mean a significant change in the costs and timing

Show Raw Text
CORRESP
1
filename1.htm

Correspondence

 Scott A.
Samuels | 617 348 1798 | ssamuels@mintz.com

 One Financial Center

 Boston, MA 02111

 617-542-6000

 617-542-2241 fax

 www.mintz.com

 March 12, 2008

 VIA EDGAR AND OVERNIGHT MAIL

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549

Attn:
    James Rosenberg

     Senior Assistant Chief Accountant

     Mail Stop 6010

Re:
Myriad Genetics, Inc.

 Form 10-K for Fiscal Year
Ended June 30, 2007

 File No. 0-26642

 Ladies and Gentlemen:

 On behalf of our client Myriad Genetics, Inc., a Delaware corporation (the “Company”), submitted
herewith is the Company’s response to comments contained in the letter dated February 27, 2008, from Mr. James Rosenberg, Senior Assistant Chief Accountant, of the Staff (the “Staff”) of the Division of Corporation Finance
of the Securities and Exchange Commission (the “Commission”) to Mr. Peter D. Meldrum, President and Chief Executive Officer of the Company, concerning the Company’s Annual Report on Form 10-K for the fiscal year ended
June 30, 2007 (the “2007 Annual Report”). The 2007 Annual Report was filed with the Commission on August 29, 2007.

 The
comments and responses set forth below are keyed to the numbering of the comments and the headings used in the Staff’s letter and are based upon information provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by the Company. Unless
otherwise stated, all references to “Myriad,” “we,” “us,” “our,” the “Company” and similar designations refer to Myriad Genetics, Inc. and its subsidiaries.

 Form 10-K for the fiscal year ended June 30, 2007

 Management’s Discussion and Analysis of Financial Condition and Results of Operations

 Overview, page 31

 Comment:

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 BOSTON | WASHINGTON | NEW YORK | STAMFORD | LOS
ANGELES | PALO ALTO | SAN DIEGO | LONDON

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 March 12, 2008

  Page
 2

1.
You do not appear to separately quantify costs incurred for your five product candidates or provide sufficient information that would allow investors to determine the reasonably
likely timing for your product commercialization and related revenue generation. Please revise your disclosure to provide the following information for each of these research and development projects. Refer to the Division of Corporation Finance
“Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following
website address:

 http://www.sec.gov/divisions/corpfin/cfcrg032001.htm#secviii.

a.
The costs incurred during each period presented and to date on the project;

b.
The nature, timing and estimated costs of the efforts necessary to complete the project;

c.
The anticipated completion date for the project;

d.
The risks and uncertainties associated with completing development or schedule, and the consequences to operations, financial position and liquidity if the project is not
completed timely; and

e.
The period in which material net cash inflows from the project are expected to commence.

 Regarding a. if you do not maintain any research and development costs by project, disclose why management does not maintain and evaluate research and
development costs by project. Provide other quantitative or qualitative disclosure that indicates the amount of the company’s resources being used on the project.

 Regarding b. and c. disclose the amount or range of estimated costs and timing to complete the phase in process and each future phase. To the extent that information is not estimable, disclose those facts and
circumstances indicating the uncertainties that preclude you from making a reasonable estimate.

 Response:

 Costs Incurred During Each Period and to Date on Each Project: Currently, the only research and development costs we track by individual drug
candidate are external costs such as services provided to us by clinical research organizations, manufacturing of drug supply and other outsourced research. In order to efficiently utilize resources, internal research costs of our drug candidates
are managed on a consolidated basis. Due to this fact, we do not track or assign to individual drug candidates internal costs of research and development such as salaries and benefits, facilities costs, lab supplies, and the costs of preclinical
research and studies. The mix of internal and external costs varies by drug candidate. Because of this distinction and our inability to report internal costs, we believe that disclosure of only our external costs would provide an incomplete picture
of the research and development costs of each of our drug candidates and would be misleading to investors.

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 March 12, 2008

  Page
 3

 In addition, we believe that disclosure of the external portion of our research and development costs
for each drug candidate would result in serious competitive harm to us. Discussions with potential business partners, contract negotiations for pricing with potential customers, and our position relative to competitors with similar drug candidates
could be negatively impacted by public disclosure of this information.

 As disclosed in our 2007 Annual Report on page 8, we are competing
against some of the largest pharmaceutical and biotechnology companies in the world. Many of these competitors are not obligated to disclose the costs of their research and development of competing products due to the lack of materiality of such
projects as compared to other research and development projects on which they are engaged, or due to the lack of materiality of such projects in relation to their financial statements taken as a whole. The specific and detailed disclosure of
research and development costs incurred by us, as requested, especially in light of the lack of equivalent disclosure by many of our competitors, would place us at an unfair competitive disadvantage. Such information would weaken our competitive
position in that a competitor would be armed with commercially sensitive information about us that would enable the competitor to alter or accelerate its competitive program in response to our historic level of expenditures or recent changes in our
level of expenditures in its programs.

 Furthermore, we believe that disclosure of such information would place us at a competitive
disadvantage in negotiating with vendors and service providers, including third-party clinical research organizations, and potential strategic collaborators. If these parties became aware of the amount of research and development expenditures
allocated to a given project as compared to our aggregate research and development costs for a particular period, they would be in a position of leverage in negotiating the terms for the services they provide or the terms of a proposed
collaboration, as the case may be, which could negatively impact our ability to secure agreements with them on optimal terms, or could even make certain proposed arrangements commercially prohibitive to us.

 For these reasons, we believe that disclosure of this proprietary information would cause us serious competitive harm. Accordingly, we respectfully
propose that we be allowed to continue reporting research and development costs on an aggregate basis.

 Nature, Timing and Estimated
Costs to Complete Each Project/Anticipated Completion Date/ Risks and Uncertainties Associated with Completion of each Project /Period in Which Material Cash Inflows are Expected: We respectfully submit that it is not practicable for us to
disclose with reasonable accuracy the nature, timing and estimated costs to complete each of our research and development projects, other than the nature and timing of our lead product candidate, Flurizan, which is in Phase 3 clinical trials. Our
next most advanced product candidate is in Phase 2 clinical trials, while all of our

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 March 12, 2008

  Page
 4

other product candidates are in Phase 1 clinical trials. Accordingly, given the early stage of development of our pipeline products and the uncertainty
inherent in the drug development and regulatory process, we are unable to ascertain or estimate with any reasonable degree of accuracy or certainty the information requested. The successful development of any drug candidate, including those that we
currently have under development, is inherently uncertain. The process of researching, developing, manufacturing, testing and bringing to market a new drug candidate takes many years. The duration of a project is dependent upon, among other things,
the type, complexity and novelty of the product and requires the expenditure of substantial resources.

 Clinical development of new drugs in
the United States is a lengthy and uncertain process that includes several steps regulated by the FDA. Preclinical research and development is followed by the filing of an Investigational New Drug Application (“IND”) with the FDA that, if
successful, allows clinical studies of the potential new drug to commence. Clinical development typically involves three phases of study: Phase I, II and III. Each phase typically takes longer to complete and is more costly than the preceding phase,
with the most significant costs associated with clinical development incurred during Phase III trials, as they tend to be the longest and largest studies conducted during the drug development process. Importantly, the actual cost and timing of a
clinical trial are dependent upon a number of factors which are not determinable until the trial is designed and/or has commenced. In addition, even after a clinical trial has been designed and commenced, there can be unanticipated delays and costs
involved with such trial. For example, the rate of completion of a trial depends upon, among other things, the rate of patient enrollment, which is itself dependent upon factors such as the size of the patient population and the proximity of
patients to the trial sites, the nature of the clinical protocol and the eligibility criteria for the trial. Furthermore, the FDA may alter, suspend or even terminate clinical trials at any time. Projects that have been progressing well may be
discontinued abruptly due to negative results of current tests or trials. Conversely, additional trials may be designed or commenced due to positive results of current tests or trials.

 In addition, estimating the period in which material cash inflows are expected and the amount of such cash flows, if any, is influenced by additional
factors such as estimating market size, competition at the time of entry into the market, and efforts required to build the marketing infrastructure and sales force necessary to successfully launch the product at points in time that may be years
into the future.

 Therefore, it is difficult, if not impossible, to predict with any degree of accuracy, especially at the early stages of
drug development, (i) the nature, timing and estimated costs to complete each project, (ii) the anticipated completion date of each project, (iii) the risks and uncertainties associated with completion of each project, or
(iv) when material cash inflows are expected. We respectfully submit that to be required to provide such information, other than the suggested disclosure below, would place the Company either in the position of furnishing information which is
potentially misleading, or information so qualified as to its accuracy as to be of little value to investors.

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 March 12, 2008

  Page
 5

 Proposed Disclosure in Future Filings: In response to this comment, we propose that our
MD&A disclosure be revised in all future filings by the Company under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), where such disclosure is applicable, and to be updated as circumstances dictate, as follows:

 Our research and development expenses include costs incurred for our drug candidates currently in human clinical trials, including
Flurizan, Azixa, Vivecon, MPC-0920, and MPC-2130. Currently, the only costs we track by each drug candidate are external costs such as services provided to us by clinical research organizations, manufacturing of drug supply, and other outsourced
research by individual drug candidate. We do not assign to each drug candidate our internal costs such as salaries and benefits, facilities costs, lab supplies and the costs of preclinical research and studies. All research and development costs for
our drug candidates are expensed as incurred.

 Our lead drug candidate, Flurizan, comprises the majority of our research and development
costs for our clinical drug candidates. Based on our current estimates, we anticipate our U.S. Phase 3 trial of Flurizan will be completed in mid-2008, and that development costs associated with a follow-on open label study will continue until we
obtain regulatory approval from the FDA, if at all. We anticipate our European Phase 3 trial of Flurizan will be completed in late 2008, and that development costs associated with this trial will end shortly thereafter. Any future revenue and cash
flow from potential sales of Flurizan are subject to a number of factors, including results from our ongoing clinical trials, regulatory approval, market acceptance of our product, and other factors. If we are able to successfully commercialize
Flurizan, we anticipate revenues and cash flows from sales of this product to commence sometime in mid- to late-2009.

 The timing and amount
of any future expenses, completion dates, and revenues for our other drug candidates is not readily determinable due to the early stage of development of those candidates.

 We do not know if we will be successful in developing any of our drug candidates. While expenses associated with the completion of our current clinical programs are expected to be substantial and increase, we believe
that accurately projecting total program-specific expenses through commercialization is not possible at this time. The timing and amount of these expenses will depend upon the costs associated with potential future clinical trials of our drug
candidates, and the related expansion of our research and development organization, regulatory requirements, advancement of our preclinical programs and product manufacturing costs, many of which cannot be determined with accuracy at this time. We
are also unable to predict when, if ever,

 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 March 12, 2008

  Page
 6

material net cash inflows will commence from our drug candidates other than Flurizan. This is due to the numerous risks and uncertainties associated with the
duration and cost of clinical trials, which vary significantly over the life of a project as a result of unanticipated events arising during clinical development, including:

•

 the scope, rate of progress, and expense of our clinical trials and other research and development activities;

•

 the length of time required to enroll suitable subjects;

•

 the number of subjects that ultimately participate in the trials;

•

 the efficacy and safety results of our clinical trials and the number of additional required clinical trials;

•

 the terms and timing of regulatory approvals;

•

 our ability to market, commercialize and achieve market acceptance for our product candidates that we are developing or may develop in the future; and

•

 the filing, prosecuting, defending or enforcing any patent claims or other intellectual property rights.

 A change in the outcome of any of the foregoing variables in the development of a drug candidate could mean a significant change in the costs and timing