.... nope you have continuously said the FDA would never entertain an AA pathway for CHF ( Post #:
61856380 Post #:
61855786 Post #:
61855972 Post #:
62297542 Post #:
62299600 Post #:
62301370 etc ) ... looks like you're telling porkies again - just sayin'
.... and you also said in Post #:
68154718 on 6th June 2023 (and I quote)
"MSB is still years off submitting for approval" when here we are less than 1 year later and MSB are having a pre BLA lodgement meeting for a CHF AA ...
hasn't even been 1 year yet so hardly "years" as you claimed ? Let's face it - you have been wrong on CHF since the DREAM-HF phase 3 trial results landed buy hey keep telling yourself something different if it makes you feel better
.... and yes we don't have to be pretend doctors to know an Accelerated Approval requires a Confirmatory Trial as it is clearly outlined on the FDA website but you have continually claimed the FDA wouldn't entertain such an accelerated approval ... simples !
https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
Accelerated Approval Program
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the
confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the
confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
(20min delay)