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DragonBear

10/21/19 10:56 AM

#104706 RE: esusun #104702

do some searching Bearspread , I am sure you can still find the info, Yes , they did grant the P3

Still waiting for that EMA link...

In your last post it was stated the EMA would not grant until manufacturing was in place.

So how can one have the EMA waiting to grant a P3, while at the same time already having granted it?

I'll repeat the same question from my previous post:

if the EMA was prepared to grant a Phase 3, then why is Kenny messing around with the FDA in the US with a mythical Phase 2b? Why the expense, and time to run a Phase 2b, followed by a Phase 3 in the US, when a Phase 3 can be run immediately in the EU?



Then again, FDA will require a Phase 1 first. Assuming mythical funding, and a mythical IND is ever submitted.