RE:RE:RE:FDA Accelerated Approval exampleImmunityBio 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.