SEC Comment Letter for Valera Pharmaceuticals Inc (CIK 0001305409) — Dec 22, 2005
Valera Pharmaceuticals Inc (CIK 0001305409)
Date: Dec. 22, 2005 · CIK: 0001305409 · Accession: 0000000000-05-063488
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File numbers found in text: 333-123288
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Mail Stop 6010 December 22,
2005
David S. Tierney, M.D.
President and Chief Executive Officer
Valera Pharmaceuticals, Inc.
8 Clarke Drive
Cranbury, NJ 08512
Re: Valera Pharmaceuticals, Inc.
Registration Statement on Form S-1
Amended December 9, 2005
File Number 333-123288
Dear Dr. Tierney:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Use of Proceeds, page 24
1. We note our prior Comment 4, your response and reissue the
comment. For each of the indications for the drug candidates that
you intend to conduct clinical trials for using these proceeds,
disclose the stage of the FDA approval process you expect to
complete
using the proceeds.
Cost of Product Sales, page 35
2. We note our prior Comment 7 and reissue it. Disclose the
nature,
cause and chronology of the issues surrounding histrelin that
resulted in lots produced that did not meet your quality control
specifications.
Notes to Financial Statements
Note 2 - Basis of Presentation and Significant Accounting Policies
Revenue Recognition, page F-11
3. We acknowledge the response to our comment 9 in your December
9,
2005 response letter. In addition to the information disclosed as
a
result of our previous comment, please include the following
disclosures:
* Regarding the actual returns and allowances of $1,283,958 for
the
nine months ended September 30, 2005, provide the portion relating
to
sales made during 2004 and sales made during the first nine months
of
2005, separately disclose the amounts from distributors and non-
distributors.
* For actual returns and allowances subsequent to September 30,
2005
disclose the portion relating to sales made during 2004, sales
made
during the first nine months of 2005 and sales made subsequent to
September 30, 2005.
* * *
As appropriate, please amend your filing in response to
these
comments. You may wish to provide us with marked copies of the
amendment to expedite our review. Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information. Detailed cover letters
greatly facilitate our review. Please file your cover letter on
EDGAR under the form type label CORRESP. Please understand that we
may have additional comments after reviewing your amendment and
responses to our comments.
You may contact Christine Allen at (202) 551-3652 or James
Rosenberg at (202) 551-3679 if you have questions regarding
comments
on the financial statements and related matters. Please contact
Michael Reedich at (202) 551-3612 or me at (202) 551-3710 with any
other questions.
Sincerely,
Jeffrey Riedler
Assistant Director
cc: Robert B. Murphy, Esq.
Pepper Hamilton LLP
600 14th Street, N.W.
Washington, DC 20005-2004
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