Cell Therapy News/Articles, page-6643

@Ratfink that is very much appreciated.

I think a lot of people have "muddied the water's" and confused the difference between FDA/ODAC discussion points and requirements needed for product approval.

The FDA discussion points were essentially put forward in a way to say "well we don't think the MOA has been established therefore we cannot approve the product based on the MOA alone. Instead, we have to look at clinical efficacy to grant approval". The FDA discussion documents released prior to the ODAC meeting essentially showed the rationale that the FDA used "all things considered, we believe the only way we can grant approval is if the product demonstrates clinical efficacy", hence the vote.

Only the discussion points relevant to the main voting question are relevant to approval and/or post-marketing requirements. All of the other discussion points that did not directly precede a vote will be used to inform clinical trial design for other diseases or recommended future R&D work.