Replies to post #366195 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I believe that the FDA and other regulators did ask for changes in the SAP which caused delays in calling data lock. When changes are submitted and nothing is requested in a prescribed number of days, it's a presumptive approval. Nothing in writing says it's approved, but company's can proceed based on what is proposed.

Nothing is ever 100% guaranteed when it comes to the FDA, but I believe we have one of the strongest cases I've ever seen. I'm a big believer that historical data ought to be what experimental therapeutics work against, I know the regulators don't agree, but in this case, I think the German's convinced the others it was wrong not to dose all patients, and that's what essentially the last third of the patients received. If that's right, how can they deny an approval that's based on comparing the SOC with the experimental therapeutic that's been added to it.

I have a friend who's a nephrologist, but he has a potentially deadly condition in which he's certain that a drug approved for other treatment that's in trials for his condition would be much better than the standard of care. He got in the trial, but unfortunately got the control treatment which he could determine with blood trials. He's dropped out of the trial and will be spending a small fortune to purchase the drug, which he can do off label. I feel for him as I don't think trials should be run in this manner, but he's doing what he has to, and fortunately he can afford it. In many ways it's similar to those in England who're raising funds to get treatment with DCVax-L. When your life is on the line, you do what you can to survive. People who are willing to take experimental treatment should get that treatment, the history of their diseases is generally well known and if the experimental drug does just a little better than the SOC and that's caused by a placebo effect, what is the harm in putting the additional drug in the Doctor's tool kit. As always, JMHO.

Gary

[marzan]

iwasadiver, we still have those original two endpoints from the original protocol still in tact in the new 6 endpoints. Ex and HappyLibrarian are just fuding. I am sure the unblinded data when adjudicated accounting for the pseudoprogression will still meet the original two endpoints with robust efficacy that will stun the naysayers speechless; rest of the world will see it that time and so the FDA and the other regulators, I have no doubt about it. So, those still debate about the new 6 endpoints and the FDA buying in are just fudsters, imo. When ATLnsder reported the European reveal of the new endpoints, the pps shot up with 3 White Soldiers candle pattern in a row to $2.50+ but the fudsters started fear mongering on warrant holders going to exercise and sell it for profit. Now the Company openly disclosed in their 10K about the new 6 endpoints submitted to all 4 RAs, I bet the pps will surpass the previous 52W high with the similar 3 White Soldiers reversal pattern starting today. Glad insiders agreed to suspend exercising their 200M+ warrants till April 30th that fudsters can't fear monger on that as well no more. I think LP has just unleashed a major plan to get the shorts real nice. It will be interesting to see how the MMs play now on returning or collecting the phantom shares they released all these months and years; they have to reap what they have been sowing I guess. I think Biden is very lucky that he will announce he cured the cancer in his first year of the Presidency; great, everything is going his way.