The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Maurice Raycroft - Jefferies LLC - Analyst
: Congrats on the progress and thanks for taking my questions. I was going to ask about the Form 483, if you can elaborate on what specific process
controls were referenced? And do you anticipate hearing back from FDA on this Form 483 or what are expectations for next steps?
Question: Maurice Raycroft - Jefferies LLC - Analyst
: And you mentioned the 45 day window. Could you hear back from FDA sooner than that? And maybe just talk about is there any risk to a delay to
the PDUFA?
Question: Maurice Raycroft - Jefferies LLC - Analyst
: Maybe last question. Just wondering if you've started off label discussions or have had any preliminary feedback as it relates to the label and
including DEB population in the label as well?
Question: Kristen Kluska - Cantor Fitzgerald & Co - Analyst
: Thanks for taking the questions. I have a few here. The first, can you clarify the 45 day window, is that from March 1 or March 15? And then you
noted that the specific comments were something that weren't atypical. So can you just maybe speak to your level of confidence in the response.
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I mean, you were able to kind of submit this within two weeks. So I guess that backs up that it was maybe something that was on your mind or
radar and that you had been preparing for this regardless?
Question: Kristen Kluska - Cantor Fitzgerald & Co - Analyst
: And then just on the cost side, there was a recent JAMA article highlighting that standard of care can cost the average patient somewhere between
$10 million to $20 million in a lifetime. So now that people are doing a lot more analysis on this, curious how you think something like this could
factor into your therapy if approved. And you know, while I respect you haven't announced the price yet, I can imagine it would be lower than
what was cited there.
Question: Kristen Kluska - Cantor Fitzgerald & Co - Analyst
: And then last question for me is just on the inspection side, other than this outstanding form 483. Are there any other large check marks or things
you're waiting for from the CMC manufacturing side of things ahead of the PDUFA date? Thanks again.
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