Justifiably. I do think they have grant approval based on safety and M2M results. I’m guessing they know one of the other countries reviewing data will bite. In normal circumstances I think the FDA would recommend phase 3 data before consideration, but the pressure is on. If the drug is as safe as we all know it is, you put it in the hands of US prescribers before it gets shipped exclusively overseas
All-Bidness.. Maybe..But in my mind the FDA is going thru the Data with a fine Tooth comb..to see what they could hang their delay on..!!! The science Safety and Efficacy of Leronlimab is impeccable..!!!
As was pointed out..ANY spare money we have..MUST be spent on Advertising our GEM..!!!
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