BlackDoggie,
Besides your good points, we should remember that FDA will have a LOT OF PRESSURE to approve the CMC part as Leronlimab will be badly needed for COVID fight.
Can you imagine them issuing a CRL when the whole world is clamoring for every milligram of wonder drug Leronlimab ???
I am going to watch, with popcorn in hand, how fast can the FDA move their rear end ..
It was time
So the CMC is granted if Leronlimab works for COVID-19. Only clinical to consider. BTW, they should be grateful and approve swiftly after we saved their rear ends in the pandemic.
Quote:The fact that the company is working with Amarex and AGC for the submission and manufacturing is comforting, as they both have significant experience in getting drugs through the approval process. What you don't want is an IMMU situation, where the manufacturing facility they built didn't meet code in certain instances, and they got a CRL.
Besides your good points, we should remember that FDA will have a LOT OF PRESSURE to approve the CMC part as Leronlimab will be badly needed for COVID fight.
Can you imagine them issuing a CRL when the whole world is clamoring for every milligram of wonder drug Leronlimab ???
I am going to watch, with popcorn in hand, how fast can the FDA move their rear end .. It was time
So the CMC is granted if Leronlimab works for COVID-19. Only clinical to consider. BTW, they should be grateful and approve swiftly after we saved their rear ends in the pandemic.
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