SEC Comment Letter for ACHIEVE LIFE SCIENCES, INC. (ACHV) (CIK 0000949858) (ACHV) — Jun 1, 2017
ACHIEVE LIFE SCIENCES, INC. (ACHV) (CIK 0000949858)
Date: June 1, 2017 · CIK: 0000949858 · Accession: 0000000000-17-019213
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-216961
Letter
Mail Stop 4546 June 1, 201 7 Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway Bothell, Washington 98011
Re: OncoGenex Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S -4 Filed May 24, 2017 File No. 333-216961
Dear Mr. Cormack :
We have reviewed your amended registration statement 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 this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply t o your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our May 17, 2017 letter .
Compe tition, page 180
Prescription Treatments, page 181
1. We note your response to our prior comment 5. Please revise to disclos e that “no apparent difference in efficacy between cytisine and Chantix ” means that the review found that the risk ratio for cytisine and Chantix was found to be in the same order of magnitude . Please also clearly disclose that only two studies were used to calculate the risk ratio for cytisine versus 27 trials for varenicline , and that evidence for varenicline
Scott Cormack OncoGenex Pharmaceuticals, Inc. June 1, 201 7 Page 2
was considered of high and moderate quality while the evidence for cytisine was considered low quality.
2. We note your response to our prior comment 6. Please revise the disclosure of the Cochrane Group review to provide the year of the first trial included in the review.
You may contact Rolf Sundwall at (202) 551 -3105 or Mark Brunhofer at (202) 551 -3494 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special Counsel, at (202) 551 - 3442 with any other questions .
Sincerely,
/s/ Erin K. Jaskot, for
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Mail Stop 4546 June 1, 201 7 Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway Bothell, Washington 98011 Re: OncoGenex Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S -4 Filed May 24, 2017 File No. 333-216961 Dear Mr. Cormack : We have reviewed your amended registration statement 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 this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply t o your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our May 17, 2017 letter . Compe tition, page 180 Prescription Treatments, page 181 1. We note your response to our prior comment 5. Please revise to disclos e that “no apparent difference in efficacy between cytisine and Chantix ” means that the review found that the risk ratio for cytisine and Chantix was found to be in the same order of magnitude . Please also clearly disclose that only two studies were used to calculate the risk ratio for cytisine versus 27 trials for varenicline , and that evidence for varenicline Scott Cormack OncoGenex Pharmaceuticals, Inc. June 1, 201 7 Page 2 was considered of high and moderate quality while the evidence for cytisine was considered low quality. 2. We note your response to our prior comment 6. Please revise the disclosure of the Cochrane Group review to provide the year of the first trial included in the review. You may contact Rolf Sundwall at (202) 551 -3105 or Mark Brunhofer at (202) 551 -3494 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special Counsel, at (202) 551 - 3442 with any other questions . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Robert Free dman Fenwick & West LLP