PharmaCyte Biotech Inc (PMCB)

[oldmusky]

I found this info interesting. I am sure it has already been posted.

"Once the IND is submitted, the clock starts ticking and the FDA has 30 days to comment. Following a review process, the FDA will either approve the IND indicating the product is “safe to proceed”, thus allowing the product to be used as an investigational drug or biologic, or a “clinical hold” will be placed on the IND application to delay or suspend the proposed clinical investigation. The sponsor is given an opportunity to address the issues cited in the clinical hold and the process then starts over again. Even a technical problem in submitting the IND can trigger a clinical hold and cause a significant delay in getting a product to market. "

The article then expounds on the most common reasons IND's are put on hold. Very educational.


Check out reason number 5. "Including massive amounts of data and assuming it is self-explanatory slows down the review process. " Hopefully this is the reason for the hold,lol.



https://criterionedge.com/common-problems-to-avoid-with-ind-applications-for-new-drugs-and-biologics/