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Posted On: 12/26/2019 8:11:05 AM
Post# of 155788
Quote:
My fear is a CRL for part 2 or more likely part 3 CMC.
Yup, I am also a bit afraid due to the lack of experience of CYDY in submitting BLA's.
The advantage we have is that is a rolling application, however haven't heard news from part 1 status and 2 and 3 will be likely come together next month.
I hope CYDY takes its time and delivers a solid BLA not leaving room for a CRL. Also, hope FDA will do the right thing and impartially study the application promptly.
We will be then ready for receiving revenue
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