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JediMozart

10/08/22 9:55 AM

#13242 RE: shoondale #13238

This was 100% the FDA adding things to ALL applicants to now have to hurdled - direct quote from the fda also mentions Covid specifically:

“Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard.”

https://www.biospace.com/article/releases/fda-accepts-covid-19-clinical-study-and-advises-on-next-steps-for-pre-ind-filing-by-medolife-rx/