NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

There is absolutely no reason to not obtain approval w/ manual manufacturing

Absolutely no reason ok how about
1. Spending ~$15 million to expand manual manufacturing only to have it made obsolete 6–9 months later by Flaskworks. And then having to throw it in the trash.
No company would sink that kind of money into a dead-end process.

2. Getting a hard NO from NICE because manual manufacturing makes the cost-per-dose far too high.
Flaskworks is literally the solution to that problem. Without automation, NICE rejection is almost guaranteed.

Those are pretty solid reasons, aren’t they? You want more ok
3. Manual is NOT scalable for commercial GBM volume
4. Manual has higher batch failure rates
5. Comparability and QA/QC must be stabilized before approval
6. NICE will not approve a product that depends on an economically broken manufacturing model
etc