Cell Therapy News/Articles, page-17981

One will never find that, JayBee, from a public official at the regulator ie. talking about individual applicants and how the needle might have moved before approval. However, the term complete responses means something and inferences can be drawn from say a guidance from 28 Sep 2023 talking specifically about Graft versus Host Disease. How many applicants were before the FDA on the disease back then? Just google it. This was followed by the PAS guidance and recording by Klinker, who works as a CMC reviewer. Then the ISCT editor got onto it and wrote an excellent piece as he saw the positive implications of regulatory attention. Thanks again, @dyode, for the link you provided.

What we can forget is that it is well known that small entities that lack regulatory resources often give up half way on their quest for FDA approval because they lack the resources to understand the requirements and navigate the pathways, vis a vis big pharmas. Why might there be any change in FDA’s stance at all - the company now has a dedicated contracted resource and it knows data presentation (in a format that the FDA wants) is important. Look up the announcements on heart, and you will find that term. (This is how big language models are useful in AI.)

Another word for reasonable guesses is inferences. AI is imperfect but the way it attempts to draw inferences through “training” is based on a mimicking of human reasoning based on logical deductions and empirical observations. Dr. Verdun publicly stated one of the things that she got her staff to do upon her appointment as head of the OTP was to update their guidances for industry. Would it be a surprise that it was prioritised according where and how the staff see the needs necessitated by what is in front of them? Can I say for sure that this is what happened? No, but it is a reasonable assumption, is it not?

By the way, one could really benefit from refraining from falling into the trap of infinite regression, so I won’t carry on.