SEC Comment Letter for TALPHERA, INC. (TLPH) (CIK 0001427925) (TLPH) — Oct 25, 2019
TALPHERA, INC. (TLPH) (CIK 0001427925)
Date: Oct. 25, 2019 · CIK: 0001427925 · Accession: 0000000000-19-014882
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File numbers found in text: 001-35068
Letter
October 25, 2019 Raffi M. Asadorian Chief Financial Officer ACELRX PHARMACEUTICALS INC 351 Galveston Drive Redwood City, CA 94063 Re:ACELRX PHARMACEUTICALS INC Form 10-K for the Fiscal Year Ended December 31, 2018 Filed March 7, 2019 File No. 001-35068 Dear Mr. Asadorian: We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2018 Business Clinical Trials, page 8 1.Please address the following regarding your disclosure of certain serious adverse events (SAEs) experienced by patients in the clinical trials of certain product candidates:
•You disclose in a risk factor on page 34 that in the phase 3 active-comparator clinical trial (IAP309), double-blind, placebo-controlled, orthopedic surgery trial (IAP311) and phase 3 multi-center, open-label study (IAP312), patients experienced serious adverse events (SAEs) that were assessed as "possibly or probably related to the study drug." Please provide us proposed disclosure to be provided in future filings identifying each treatment-related SAE "possibly or probably" related to Zalviso.
•Further on page 9, you disclose that in the IAP312 study “A total of 5 patients experienced serious adverse events, but all were considered unrelated to study drug
FirstName LastNameRaffi M. Asadorian Comapany NameACELRX PHARMACEUTICALS INC October 25, 2019 Page 2 FirstName LastName Raffi M. Asadorian ACELRX PHARMACEUTICALS INC October 25, 2019 Page 2 by investigators.” This disclosure appears to contradict your disclosure on page 34. Please clarify for us whether the SAEs in the IAP312 study were related or unrelated to Zalviso. Revise such disclosure in future filings to reconcile the apparent contradiction. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 if you have any questions. Sincerely, Division of Corporation Finance Office of Life Sciences
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October 25, 2019
Raffi M. Asadorian
Chief Financial Officer
ACELRX PHARMACEUTICALS INC
351 Galveston Drive
Redwood City, CA 94063
Re:ACELRX PHARMACEUTICALS INC
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 7, 2019
File No. 001-35068
Dear Mr. Asadorian:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Business
Clinical Trials, page 8
1.Please address the following regarding your disclosure of certain serious adverse events
(SAEs) experienced by patients in the clinical trials of certain product candidates:
•You disclose in a risk factor on page 34 that in the phase 3 active-comparator clinical
trial (IAP309), double-blind, placebo-controlled, orthopedic surgery trial (IAP311)
and phase 3 multi-center, open-label study (IAP312), patients experienced serious
adverse events (SAEs) that were assessed as "possibly or probably related to the
study drug." Please provide us proposed disclosure to be provided in future filings
identifying each treatment-related SAE "possibly or probably" related to Zalviso.
•Further on page 9, you disclose that in the IAP312 study “A total of 5 patients
experienced serious adverse events, but all were considered unrelated to study drug
FirstName LastNameRaffi M. Asadorian
Comapany NameACELRX PHARMACEUTICALS INC
October 25, 2019 Page 2
FirstName LastName
Raffi M. Asadorian
ACELRX PHARMACEUTICALS INC
October 25, 2019
Page 2
by investigators.” This disclosure appears to contradict your disclosure on page 34.
Please clarify for us whether the SAEs in the IAP312 study were related or unrelated
to Zalviso. Revise such disclosure in future filings to reconcile the apparent
contradiction.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 if you
have any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences