RE:RE:RE:Small correction to tableenriquesuave wrote: Could the FDA be considering to give AA for Ruvidar? BTD is often given after much less data than we already have. I'm not expecting AA right away, but who know? As long as we get BTD and a path to AA.
enriquesuave...Interesting question...
In this link...
https://pharmdevgroup.com/fda-expedited-programs-explained/ Page 7...Under "Conclusion"...
"Expedited programs(Fast Track, BTD, AA,Priority Review) frequently
overlap and it is not unheard of for drug development programs to make
simutaneous use of three or four of them".
In short, Theralase could with sufficient data ask for BTD and AA at the same time.
Just imagine if Theralase was to receive both BTD & AA approval within a very short time.
The SP jump would be interesting to see.