Replies to post #757192 on NorthWest Biotherapeutics Inc (NWBO)

[froggmister]

Here's my two cents FWIW. The most credible reason to reject the DCVax-L application is the trial design which shifted from placebo controlled to contemporaneous matched external controls using External Control Populations (ECPs). Several prominent bears on this board disagree with the JAMA authors and signers who assert that with this design the trial "was associated with a clinically meaningful and statistically significant extension of overall survival in both nGBM and rGBM."

I would have expected that if the ECP design had been worthy of rejecting the application that would have occurred either A) upon application (they would have not accepted it) or B) after the first CHM meeting which occured in July. Subsequent to that there have been numerous reports of extensive inspections. Why send inspectors all over the world and significant expense to the UK taxpayer if you are going reject the application anyway?

Now, could there be a manufacturing issues that, despite many attempts going back and forth to remedy, cannot be solved? Maybe, but that seems highly unlikely to me. It's a complex treatment process, a complex application, and I believe it will be soon approved.
-Frogg

[Chiugray]

Krisgo, If as rumored, inspections took place in Jan and Feb 2025, then we are continuing to move along. Just thoughts, but what could be happening is an effort by the MHRA to time the approval of DCVax-L to coincide with the approval and validation of Flaskworks' Eden automation system.

I think this because the Eden validation process has likely been running in parallel all along. Also I believe the MHRA considers this, knowing that once a drug approval happens, the company is obligated and will be pressured to invest heavily in the ramp up for commercialization. These would include long-term, hard financial commitments (especially long tail order requirement items), especially in manufacturing. If in fact the approval decision for Eden was right around the corner, or potentially within a couple of months, those would be the judgement calls they would make. And I assume nothing is clear and simple with regards to a couple of months either, given the MHRA has been backlogged.