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sushifishman

09/02/22 1:12 PM

#42420 RE: rwa3848 #42419

They have had 15 months to get a pre bla


There is something wrong here

Cheers
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G8TSTFL

09/02/22 1:58 PM

#42421 RE: rwa3848 #42419

So I'm really hoping they have already requested a meeting, possibly in August.
They did say they have been talking to the FDA.
To listen to Geert they plan on submitting the BLA in 2022.

From a previous post of mine:
'After the meeting has been requested, the FDA will respond to a Type B meeting request within 21 days.' AND ‘ The FDA intends to schedule all Type B meetings to occur within 60 days of receiving the written meeting request.’

In order to make the end of the year, while addressing any of the FDA’s concerns, I think they need this meeting in mid-October.