PDUFA FDA Approval

robertbanking

Hello you very wonderful and amazing individuals that make up these forums. I sincerely hope you are doing well and keeping positive.

I have a few biotech stocks in my portfolio that are coming up for PDUFA FDA decision on whether a product can be licensed to treat patients and make the company revenue. I know there is a good chance of approval at this stage, as the company has had to conduct very rigorous tests and pass all the clinical trials, without any serious side effects.  

I kindly wondered what percentage chance of an FDA approval there is at this final stage please? What are the FDA kindly looking at when they are conducting this review please? If anyone kindly had any thoughts on this i would be forever grateful and it would be highly appreciated.

Sending you lots of good wishes and i truly hope you continue to have a fantastic weekend. All the very best to you and take care. 

masonic

The following questions should guide you to form a view on the likelihood of approval... What were the outcomes of the clinical trials? Does the product offer clinically relevant benefits over the current standard of care? Were any safety issues identified? Do the benefits outweigh the risks taking into account the indication and treatment regime? What were the limitations of the studies?

LHW99

You might find something useful here?

https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022#predictability