Post by
O12009 on May 18, 2023 7:18am
Fast track approval
When Theralase was granted fast track approval part of that perk was contact with the FDA to make sure they were doing the "right things " to keep them on track. AKA pre approval?
Comment by
Alamir1111 on May 18, 2023 8:41am
Ibrx was granted fast track designation to guide them. Guess somebody forgot to mention that production procces got some issues.
Comment by
Lesalpes29 on May 18, 2023 8:43am
Good comparaison... lol I may use the ignore button soon!
Comment by
Beano349 on May 18, 2023 8:50am
Sesen bio is a similar example also. They had other trail issues but also didn't seem to do well with guidance prior to the surprise rejection.
Comment by
enriquesuave on May 18, 2023 9:35am
Sesen bio never got BTD, they only had fast track. I don't think data was good enough for BTD. Imho. Adstiladrin got BTD and then CRL for manufacturing to finally get approval 19 months later.