SEC Comment Letter for KALA BIO, Inc. (KALA) (CIK 0001479419) (KALA) — Jun 14, 2017
KALA BIO, Inc. (KALA) (CIK 0001479419)
Date: June 14, 2017 · CIK: 0001479419 · Accession: 0000000000-17-020841
AI Filing Summary & Sentiment
Reasoning
Letter
Mail Stop 4546 June 14 , 2017 Mark Iwicki Chief Executive Officer Kala Pharmaceuticals, Inc. 100 Beaver Street, Suite 201 Waltham, MA 02453
Re: Kala Pharmaceuticals, Inc. Amendment No. 4 to Draft Registration Statement on Form S-1 Submitted June 2 , 2017 CIK No. 0001479419
Dear Mr. Iwicki :
We have reviewed your amended draft 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 providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circum stances or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our April 26, 2017 letter.
Prospectus Summary Our Product Candidates, page 2
1. Please provide the basis for your estimate that dry eye disease affects approximately 33 million people in the U.S.
Manufacturing, page 112
2. We note your disclosure that one of your testing laboratories has received a Form FDA 483 containing two inspectional observations. Please revise your disclosure to describe these inspectional observations.
Mark Iwicki Kala Pharmaceuticals, Inc. June 14, 2017 Page 2
You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 - 3679 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202 -551-8776 or me at 202-551-3675 with any other questions.
Sincerely,
/s/ Suzanne Hayes
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Mail Stop 4546
June 14 , 2017
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453
Re: Kala Pharmaceuticals, Inc.
Amendment No. 4 to
Draft Registration Statement on Form S-1
Submitted June 2 , 2017
CIK No. 0001479419
Dear Mr. Iwicki :
We have reviewed your amended draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circum stances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
April 26, 2017 letter.
Prospectus Summary
Our Product Candidates, page 2
1. Please provide the basis for your estimate that dry eye disease affects approximately 33
million people in the U.S.
Manufacturing, page 112
2. We note your disclosure that one of your testing laboratories has received a Form FDA
483 containing two inspectional observations. Please revise your disclosure to describe
these inspectional observations.
Mark Iwicki
Kala Pharmaceuticals, Inc.
June 14, 2017
Page 2
You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 -
3679 if you have questions regarding comments on the financial statements and related matters.
Please contact Dorrie Yale at 202 -551-8776 or me at 202-551-3675 with any other questions.
Sincerely,
/s/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Lia Der Marderosian, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP