Replies to post #741188 on NorthWest Biotherapeutics Inc (NWBO)

[dmb2]

Doc is not delusional but a positive visionary. We have all seen problems with US govt agencies in recent years and FDA is not immune. I mentioned before that there have been more companies looking to the UK for first product approval due to what I will say are complications with FDA. We have all seen problems with market corruption in recent years and most of us are keenly aware of what that has caused companies like NWBO and many more. There is hope that the corruption which has infected US institutions will start to correct and starting with FDA and Citadel may be great steps, hopefully sooner than later.

There is little chance info on the clinical hold will come out prior to FDA approval and maybe not even after as there is a good chance it is the reason NWBO changed direction toward MHRA for primary approval. I don't think NWBO will call out FDA as they are not ready nor willing to be a leader in that one too.

GLTA

[Doc logic]

learningcurve2020,

Not a chance that FDA told NWBO to run another trial because they interfered with the first one and for good reason. They required a crossover which helped rGBM patients as the data proves out. They also reduced the powering of the trial by agreeing not to enroll the last 17 SOC/placebo patients even when all remaining treatment arm patients were enrolled after the screening hold. That is CLEAR interference and if not for a good reason that interference would need to be disclosed publicly. Bottom line is NWBO would have cause against FDA for interference.
The issue as I see it and seems pretty clear is and always has been the business model based on limitations created by the artisan manufacturing model. There is simply no way to get past all the complexities of batch by batch production unless the product is going to be a botique style treatment like Provenge has been and it’s not. This DC process treatment is likely being prepared to become SOC for GBM, rGBM and possibly lower grade gliomas and it is expandable as a platform treatment for all resectable solid tumors. That is going to create a tremendous amount of demand which FDA and NWBO probably agreed should have accomodations being worked out for ahead of any initial approval because just the demand for GBM, rGBM and potentially lower grade gliomas would place a huge burden on any company trying to utilize artisan method with costly clean rooms that would not be needed for very long let alone the desire by regulators for more closed system processes out of safety concerns. Not a requirement mind you, just a big headache dealt with by both FDA and NWBO before it becomes an intolerable migraine.
As far as the market cap, the time risk and lack of guidance regarding true in stone dependable time lines regarding time to profitability keeps many investors away which makes the manipulation all that much easier. Both forces are at work. Development work often does not follow predictable time lines and that makes management the easy scapegoat target even though they are not directly the cause of delays.
Lastly, FDA has been known to be under the influence of others at times so placing full confidence in them is not always the best option especially for a development stage biotech company. Best wishes.