maybe I shouldn’t have used the word FDA conclusion... I accept that was not accurate.
However, the current positions of the FDA are pretty clearly stated and that is all I am trying to convey here... if one were to only read the MSB submission, and take what they say as gospel, then that isn’t correct either... as I am assuming that the FDA has had the data presented by MSB ahead of this meeting and have had a chance to consider it... and from that they have put it to the ODAC for their opinion.
FDA ODAC Meeting Material discussion analysis, page-370
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