Replies to post #38071 on Cytodyn Inc (CYDY)

[BlackDoggie]

I disagree. Rolling submission and rolling review are two different things. Previously, the FDA had allowed CytoDyn to submit a BLA on a rolling basis, but would only review the complete final product. That’s basically worthless. Now, the FDA is planning to actually review pieces as they come in, expediting the overall time to approval granted that the last piece gets in when it always would have.

This is news, this is important, and it does signal FDA support in some manner.

[Emergcy]

Thank you for the lesson. As I said, biotech isn't my area of know how. It sound to me like a privilege. However, they informed and it is good that they did.

[BlackDoggie]

I MAY be incorrect with my previous assertion, and it would be a good question for NP. As others have mentioned, FDA permission for a rolling submission was previously stated by the company. Either way, Rolling Review is not standard FDA practice any more than Fast Track - with which RR tends to be associated - or Breakthrough, ODD, etc. They’re all designations or privileges granted to specific drugs.

[misiu143]

" our request for rolling REVIEW of our planned BLA for Pro 140.

Amatuer , there is nothing standard here , this is a big deal , and it shows confidence in our drug !!!!

And this way at the end approval should be done much quicker ..

IMO as always ...