Gabagool, I think that it’s you who is “pivoting” & distracting with your medical analyses & fact-free opinions…
Fact ✅️: I was not referring to “a few phase 1 readouts.” Combo research with DC platforms have reached PII.
DCVax®-L is “unprecedented” in a number of ways, but there are some other novel cell-based examples to consider in terms of RA review time, such as Biogen’s Tofersen.
Beyond Tofersen, you can find a few other relatively recent examples too…
🔑Key Insight: Advanced complex cell or gene therapies can stretch timelines due to CMC validation.
Manufacturing is a huge factor to consider in regulatory review of personalized, cutting-edge technologies. That’s why the Advent acquisition during NWBO’s MAA review is very telling!
Example: ROCTAVIAN (valoctocogene roxaparvovec) is a gene therapy (ATMP)
MAA submission was in Nov 2019, and approval was in Aug 2022 (2 yrs & 9 months). Even excluding the brief 7-month application pause/resubmission period, the regulatory review still exceeded 2 yrs.
Extended reviews might look uncommon, but that’s because novel cell therapies are relatively new & uncommon—there aren’t many relative to the huge number of older pharma products on the market.
The dawning of a new era in targeted cell & gene technology is underway!
Market Data 
Markets 
AI
