RE:RE:RE:RE:RE:FDA Accelerated Approval exampleRumpl3StiltSkin wrote: ScienceFirst wrote: ImmunityBio has submitted its BLA. It can take the FDA up to 2y (mostly 1y) to approve it as it involves going through the verification of their manufacturing facilities and processes.
TLT will rather go the NDA route, which is less complex.
How long does it take for BLA approval?
At the end of your Phase III trial, you can submit your BLA to the FDA, but it can still take up to two years to gain approval.
Would TLD1433 be considered a BLA or a NDA? I found this in an interview:
If Theralase is able to complete the preclinical studies using TLD 1433, the company will be in a position to have a pre-New Drug Application(pre-NDA) meeting sometime during Q4 20xx and, potentially, be on track to file the NDA after.
So BLA requires a longer approval process than a NDA. If accurate, by the time ImmunityBio obtains its BLA approval, we will have accumulated enough statistically significant data to know if we could beat them.
Aren't these the guys that have to pair with BCG? While TLT is stand alone?? And their treatment takes many dosings? I think all TLT needs to do is match them... I don't think they are really going to be a popular option once 1433 is out there.
Good posts...considering there is currently no well-established & non-surgical standard of care for this indication, we are left with with primarily two salvage therapy options....one of which is not yet FDA approved, but is currently being used for this indication & is also in a Ph 3 randomized controlled study that is comparing BCG vs an intravesical drug combo option in high-grade NMIBC. The 2nd is FDA approved Keytruda, which as we know is not a highly encouraging option (12 month CR of 19%).
Considering the very limited salvage options that currently exist for an elderly patient population that can be very diverse, fragile & refractory, we simply need more diverse options, especially ones that are more efficient, less treatment-intensive & more patient-friendly. Keytruda's approval should be seen as encouraging, & the fact that this is currently the "only" FDA approved salvage option (outside of poorly performing Valrubicin), I don't believe the current threshold for approval will be unexpectedly high. Imo, if we are anywhere in the same efficacy "ballpark" as ImmunityBio, we should be good to go...& it's a pretty big ballpark. JMO.