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Dan88

04/05/21 9:37 AM

#367268 RE: marzan #367266

I believe marzan not only has the company applied to FDA for FT but we are now waiting for decision of FDA any day.

And yes the company might also apply for FT before, but this time things are fundamentally different because the unblinded data is available for FDA to review.

I guess any day now we may hear the new about Fast Track.
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hankmanhub

04/05/21 11:50 AM

#367311 RE: marzan #367266

I think that the Fast Track application happens together with the BLA submission, so if no BLA, no Fast Track