Replies to post #136269 on PharmaCyte Biotech Inc (PMCB)

[skyhigh50]

Nice information. Considering the files was accepted without issues. I feel better about clearing up the issues with the hold.

[A2Z]

Oldmusky are you saying the fda has this under review.

Hmmm I guess you can change the rules in the middle of the game.

To me... since they put it on hold there is a concern that we were not able to satisfy them with the answers we gave. That all took place in the first 2 weeks. If it was something simple surly we could of answered or solved in the remaining 2 weeks.

I think if fda needed more time to comprehend something that surly should been announced and let our company and everyone know.

Sorry I can’t by that excuse. Remember we were spoon fed that the reason it took so long to submit IND we had to make sure everyone was perfect.

Evidently it’s not.

[thenewmixer]

check out the heading the best of the best couldn't avoid this problems

Common Problems to Avoid with IND Applications for New Drugs and Biologics