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Re: None

Sunday, 05/07/2017 5:31:11 PM

Sunday, May 07, 2017 5:31:11 PM

Post# of 232
CC Notes regarding 483

Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [8]

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Good morning, Ken, thanks for the question. FDA completed their re-inspection of our facility as part of the NDA review late yesterday afternoon. As Amar mentioned 483 was issued.

We were pleased during the re-inspection that the FDA investigator was able to confirm our corrective action plan from prior observations and indicated that there was no further follow-up necessary to close out those issues. This was a new investigator, not the same investigator from prior inspections, and their primary focus in the 483 relates to a particulate matter issue as part of our manufacturing process. The issue relates primarily to completion of an investigation that we have underway in regard to the particulate matter, solidifying specifications for in-process 100% visual inspection of our inserts as well as enhancing our operator training.

We feel quite comfortable that we have the situation under control. And we are preparing responses to the 483 as of this morning in anticipation of responding within 15 calendar days to the agency. In addition to the particulate matter issue FDA raised a couple of observations in regard to analytical method testing to be completed as well as some other issue related to quality oversight of batch records.

So in summary, we believe that each of the observations raised by FDA during this continuous improvement review of our fully developed manufacturing process are handlable and will be resolved in our response to FDA. We are also pleased that the collaborative nature of our NDA review has continued between the various offices of FDA, and we are marching toward that PDUFA date and expect that we can resolve the 483 issues in a timely manner.
Donald Ellis, JMP Securities - Analyst [11]

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Thank you and good morning guys. Regarding the 483s, will there be a requirement for a re-inspection?

And then my second question is regarding the C code pass-through. What gives you comfort that a pass-through code will be granted for this product?

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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [12]

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So I will let Eric answer the question on the 483. And then Andy, maybe you can weigh in after that on the commercial stuff.

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Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [13]

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As a result of the completion of the re-inspection yesterday afternoon there is no indication of a Andrew Berens, Morgan Stanley - Analyst [23]

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Is there anything in their observations that you think could delay the action date specifically?

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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [24]

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Nothing that we can currently see. I think these as you know probably 90%-plus inspections have a 483. The question is what are the nature of the issues in the 483.

We think these are resolvable issues. And we have responses some already prepared and some being prepared to address them in a timely fashion.re-inspection needed going forward.

And then I guess what specifically gives you confidence that it's not going to happen? Because it seems like there is a number of things that were brought up on this 483.

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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [33]

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Yes, because most of the issues that are brought up on the 483 are not long-term type of issues. These are quality system and methodology type of things that are to be addressed by modifications of training procedures, documentation and in one case a test method that is a relatively short-term type of a test method. But Eric can comment a little on that.

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Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [34]

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In addition to that we have commercial product in our controlled inventory. And that was something FDA was looking for as part of this re-inspection as a sign that we are ready to go for a commercial launch.





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