Replies to post #451976 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I’m not sure sitting on the shelf is a fair context. Dr. Bosch worked his arse off since the phase I Direct trial in order to:

1. Correlate hundreds of phase I observations from, blood, tumor tissue, biochemistry, DC phenotype and genotype, tumor and patient status before during and after therapy was ultimately (unfortunately) stopped, etc. fact.
2. Fine tune the process, from what he learned in phase I, that develops and picks out the ultimate partially matured DCs, and where not possible because of some DC deficiency, devising the process to get DCs to become partially matured warriors. Fact.
3. Developed and patented these methods so that his therapy does not go into the waste bin of unprofitable breakthroughs. Fact.
4. Await the end to the intolerably slow (likely) approval of L, so that his therapy can be well funded in phase ii/iii trials for all solid tumor indications, imo.

[The Danish Dude]

SUKUS: The next one would be a lot faster I think. I think similar to the solid tumor trial they did on DCVax-Direct trial phase 2. Imo.

exwannabe: The Direct P1/2 was first posted in summer 2013. The P2 phase was supposed to start around end of 2014 or so. 8 years later it has not even opened for enrollment. And that would still have not been pivotal.

Direct has now been on the shelf for over 7 years gathering dust.

Only in NWBO-land would this be fast.

Not so fast. You keep forgetting.

UK finalises biosimilar guidance designed to improve on EMA starting point

https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products