With the aGVHD decision from the FDA meeting they released it straight away to the market because it was a significant change with a material impact. They didn't have to wait 30 days to receive the formal minutes...
Not really what is says in the announcement though is it ?
It looks like they gave their opinion on the meeting but had to wait for a definitive answer from the minutes .... you may also note that the AA path looks to have been given the boot as they now seem to have reversed and are looking at a resubmission of the original BLA
Perhaps they are simply taking a different stance this time around especially given Novartis are involved, but as I mentioned in my previous post you are (like myself) just speculating unless you work for the FDA, Novartis or MSB and were at that meeting
I am also confused why you 'liked' my post when your rebuttal 'appears' to disagree with its content - seems weird ?
whytee liked your post in the thread Cell Therapy News/Articles.
Cell Therapy News/Articles, page-10375
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