NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

MAVEN Bio99

What is the timeframe within which the FDA can expedite the approval of a cancer treatment that addresses a significant unmet medical need, such as recurrent glioblastoma, demonstrates life-saving efficacy where approaching 1,000 treatment trials have failed, and manifests moderate side effects, in the case of $NWBO DCVax, none. Noteworthy examples like Blinatumomab and Zanubrutinib received FDA approval within 75 and 84 days, respectively, and I have not even looked at this exhaustively...
I believe the UK's approval process for DCVax will conclude in under 60 days after submission (which the company has stated will occur the end of September) and will precede FDA approval. This will serve as the perfect backdrop, allowing the FDA to expedite its approval process even more rapidly than for the previously mentioned treatments. And the fact that the government has exploded the size of the CBER office into a super-office to evaluate cell therapies like DCVax is no accident. They want curative nontoxic treatments...
By the way, when do companies often submit cancer treatment BLA applications to the EMA? My analysis of 10 years of applications, reveals 30-40 days post FDA. So it's all going to happen quite quickly. Far faster than tens of millions of shares can be covered (or hundreds of millions of naked shares--if that is indeed the case). So good luck to all!

https://x.com/bio99_bio99/status/1698229150862241999?s=61&t=VjmZvMJYnBGdSJ91WL-h7g