Reg, all your cut and pasted stuff from (I'm assuming and I recognize it) looks good and relevant.
Kudos (genuinely) for finding a good source doc. I'd guess you are quoting from a guideance document that Bauer referred to at ODAC.
But part of your analysis I don't agree with.
You wrote:
, I would suggest that an independent lab validated the work and , as they often remind us, they have constant dialogue with the FDA. Highlighted in purple is where the FDA says- hey , send us yo data and we will check it.
"independent lab" I don't think so reg, if an independent lab validated the work - I think they'd mention that. Why not - it would add some credibility to anyone wondering how validated the validated potency assay could be.
they have constant dialogue - everytime I here that phrase or its equivalent I think of movies where remote space craft are communication with earth and the communications takes weeks or months to get sent back and forth - its regular, its constant, its a dialogue - but there are long lag times in the feedback - I think that is what actually happens in communications between the FDA and just about anyone (including MSB).
If you look at some of the SOPPs that the FDA detail how they communicate with applicants, that impression (that communication has long delays in it) is pretty easy to form.
Of course "You may provide data collected from potency assay validation studies in
electronic format to facilitate statistical evaluations by the CBER review committee,"
They probably did provide exactly that in the IND file update - but that doesn't mean that the FDA has given them any actual feedback yet.
To be clear I have not listened to the update webcast if it has happened yet but I gather from reading comments others have and that SI said something like the FDA/CBER is meeting their own timeframes (which I translate as - they are late gettting back to us but what can we do - we have to accept that it is in their hands).
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