Well the FDA has until monday to blink . But i agree the FDA is yanking the chain here. And im not surprised one bit. Delay city... oh well i aint selling and i predicted we may see down to 10 bucks to clear out the suckers
it means they need more/better data to support approval.
They wouldn't ask for more if they didn't like what they already see. The government has no problem shutting down trials that they are funding when data isn't good.
A BLA requires more than one trial. A 200 patient trial is tiny. It makes sense to make it bigger for the BLA.
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