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Posted On: 04/28/2020 3:58:15 PM
Post# of 155142
After all the good news and findings yesterday, it looks like CC Partypeople have a hangover and Analyst figuring numbers and waiting for the next kick (news).
I read the FDA approval time after BLA is submitted:
From Wikipedia:
https://en.wikipedia.org/wiki/Biologics_license_application
As we are begging FDA for Compassionate Use Approval for Covid-19, that could come in 6 - 8 weeks or might anytime as results are excellent in 3-7 days.
Doesn't it makes sense to approve both HIV and Covid as they have studied (HIV) paperwork for so long ?
I read the FDA approval time after BLA is submitted:
From Wikipedia:
Quote:
A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
https://en.wikipedia.org/wiki/Biologics_license_application
As we are begging FDA for Compassionate Use Approval for Covid-19, that could come in 6 - 8 weeks or might anytime as results are excellent in 3-7 days.
Doesn't it makes sense to approve both HIV and Covid as they have studied (HIV) paperwork for so long ?
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