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DonDonDonDon

07/29/21 1:52 PM

#31527 RE: 10nisman #31526

FDA tells $HGEN you're not getting EUA and your study needs to be expanded and redesigned if you want any shot at approval. How is this bullish?


They wouldn't expand a trial if they didn't believe in it. Most ACTIV trials have been discontinued. Their intention might be to facilitate getting the BLA.

PITrader87

07/29/21 1:59 PM

#31528 RE: 10nisman #31526

FDA tells $HGEN you're not getting EUA



hmm I haven't seen that news anywhere .. link to source, please & thanks!

Also you forgot to explain why the tax accounting issue was incorrect .. very interested & thanks again in advance!