SEC Company Response from Modular Medical, Inc. (MODD) (CIK 0001074871) (MODD) — Oct 18, 2019
Modular Medical, Inc. (MODD) (CIK 0001074871)
Date: Oct. 18, 2019 · CIK: 0001074871 · Accession: 0001019056-19-000552
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-232377
Referenced dates: October 17, 2019
Letter
VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Amendment No.2 to Registration Statement on Form S-1 Filed on October 8, 2019 File No. 333-232377
Re: Modular Medical, Inc.
Dear Mr. Jones:
Modular Medical, Inc. (the “Company”) hereby submits this letter in response to comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in its letter dated October 17, 2019 (the “Comment Letter”) relating to the above-referenced Amendment No.2 to Registration Statement on Form S-1 dated October 8, 2019 (the “Registration Statement”).
Set forth below in bold are the Staff’s comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds to the numbered comment in the Comment Letter and includes the caption used in the Comment Letter. Immediately following each comment is the Company’s response to that comment. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Registration Statement.
Pre-Commercialization Steps, page 3
1. We note your disclosure that you expect that the pre-submission conference with the FDA will be conducted near the end of the third quarter of 2019. Please update your disclosure and include any material reasons for any delay.
To comply with the Staff’s request, the Company has revised the above noted disclosure referenced by the Staff in the “Prospectus Summary – Pre-Commercialization Steps” and in the “Business – Governmental Regulations” sections of the prospectus to read as follows:
“We currently expect that such conference will be conducted during the fourth quarter of 2019.”
The Company has tentatively scheduled a pre-submission conference with Courtney Lias, Director, Division of Chemistry and Toxicology Devices of the FDA, for November 15, 2019. The Company, however, respectfully submits to the Staff that, because such conference date is tentative and not final, the Company, to ensure compliance with its disclosure obligations, has not disclosed in the prospectus the tentative scheduled date of the conference. Rather, the Company has disclosed on pages 3 and 32 that it currently believes such conference will occur in the fourth quarter of 2019. The Company hereby informs the Staff that the reason that its pre-submission conference with the FDA did not occur in the third quarter of 2019 was that the Company wanted to continue working on its 510(k) application to make sure it narrowed down any issues and questions that it would want to discuss with the FDA at the pre-submission conference in order to optimize its time with the FDA. The Company further informs the Staff that no material event or circumstance has occurred or has become known to the Company that caused the Company to delay its conference date. Additionally, the Company does not believe that the change in the timing of such conference will change the timing of the Company’s 510(k) submission to the FDA.
West Valley Parkway, Suite 203, Escondido, CA 92025 - 760.392.1343 – modular-medical.com
Government Regulations, page 32
2. We note your response to prior comment 2; however, where you attribute statements in your prospectus to your consultants as you do here and on page 2, the consultants’ consent should be filed as an exhibit to your registration statement.
As indicated in response 2 of the Company’s October 8, 2019 response letter to the Staff, the Company does not believe any of its consultants are “experts” as that term is defined in Section 7 of the Securities Act, which would require their consents to be filed as exhibits to the Registration Statement pursuant to Rule 436 of the Securities Act. However, the Company understands and acknowledges the Staff’s comment 2 in its Comment Letter and, in response thereto, the Company has removed statements in the prospectus attributable to the Company’s consultants (including Susan Finneran and Kirk Brote) to avoid giving a reader the impression that such statements are attributable to an “expert.”
Please contact either me or our outside counsel copied hereon, Lawrence Nusbaum and Howard Mulligan of Gusrae Kaplan Nusbaum PLLC, at 212-269-1400, with any questions that you may have.
The Company hereby respectfully submits this letter as of the date first above written.
Very truly yours,
/s/ Paul DiPerna
Show Raw Text
CORRESP
1
filename1.htm
October 18, 2019
VIA EDGAR
Securities and
Exchange Commission
Division of
Corporation Finance
100 F Street,
N.E.
Washington,
D.C. 20549
Attn: Thomas Jones
Re: Modular Medical, Inc.
Amendment
No.2 to Registration Statement on Form S-1
Filed
on October 8, 2019
File
No. 333-232377
Dear
Mr. Jones:
Modular
Medical, Inc. (the “Company”) hereby submits this letter in response to comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) set forth in its letter dated October 17, 2019
(the “Comment Letter”) relating to the above-referenced Amendment No.2 to Registration Statement on Form S-1
dated October 8, 2019 (the “Registration Statement”).
Set
forth below in bold are the Staff’s comments from the Comment Letter. For your convenience, each of the numbered paragraphs
below corresponds to the numbered comment in the Comment Letter and includes the caption used in the Comment Letter. Immediately
following each comment is the Company’s response to that comment. Defined terms used but not otherwise defined herein have
the meanings ascribed to such terms in the Registration Statement.
Pre-Commercialization
Steps, page 3
1. We
note your disclosure that you expect that the pre-submission conference with the FDA
will be conducted near the end of the third quarter of 2019. Please update your disclosure
and include any material reasons for any delay.
To
comply with the Staff’s request, the Company has revised the above noted disclosure referenced by the Staff in the “Prospectus
Summary – Pre-Commercialization Steps” and in the “Business – Governmental Regulations” sections
of the prospectus to read as follows:
“We
currently expect that such conference will be conducted during the fourth quarter of 2019.”
The Company has tentatively scheduled a pre-submission conference with Courtney Lias, Director, Division of
Chemistry and Toxicology Devices of the FDA, for November 15, 2019. The Company, however, respectfully submits to the Staff that,
because such conference date is tentative and not final, the Company, to ensure compliance with its disclosure obligations, has
not disclosed in the prospectus the tentative scheduled date of the conference. Rather, the Company has disclosed on pages 3 and
32 that it currently believes such conference will occur in the fourth quarter of 2019. The Company hereby informs the Staff that
the reason that its pre-submission conference with the FDA did not occur in the third quarter of 2019 was that the Company wanted
to continue working on its 510(k) application to make sure it narrowed down any issues and questions that it would want to discuss
with the FDA at the pre-submission conference in order to optimize its time with the FDA. The Company further informs the Staff
that no material event or circumstance has occurred or has become known to the Company that caused the Company to delay its conference
date. Additionally, the Company does not believe that the change in the timing of such conference will change the timing of the
Company’s 510(k) submission to the FDA.
800
West Valley Parkway, Suite 203, Escondido, CA 92025 - 760.392.1343 – modular-medical.com
Government
Regulations, page 32
2. We
note your response to prior comment 2; however, where you attribute statements in your
prospectus to your consultants as you do here and on page 2, the consultants’ consent
should be filed as an exhibit to your registration statement.
As
indicated in response 2 of the Company’s October 8, 2019 response letter to the Staff, the Company does not believe any
of its consultants are “experts” as that term is defined in Section 7 of the Securities Act, which would require their
consents to be filed as exhibits to the Registration Statement pursuant to Rule 436 of the Securities Act. However, the Company
understands and acknowledges the Staff’s comment 2 in its Comment Letter and, in response thereto, the Company has removed
statements in the prospectus attributable to the Company’s consultants (including Susan Finneran and Kirk Brote) to avoid
giving a reader the impression that such statements are attributable to an “expert.”
Please
contact either me or our outside counsel copied hereon, Lawrence Nusbaum and Howard Mulligan of Gusrae Kaplan Nusbaum PLLC, at
212-269-1400, with any questions that you may have.
The
Company hereby respectfully submits this letter as of the date first above written.
Very truly yours,
/s/ Paul DiPerna
Paul DiPerna
Chairman, Chief Executive Officer,
Chief Financial Officer, Secretary and Treasurer
CC: Lawrence G. Nusbaum, Esq.
Howard F. Mulligan, Esq.
800
West Valley Parkway, Suite 203, Escondido, CA 92025 - 760.392.1343 – modular-medical.com