Replies to post #499745 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

HyGro,

If all you were saying was true, and if you truly worked in the industry, if you see the evidence of efficacy in the data and believe that it's possible that DCVax-L and Direct could potentially be a new paradigm in the treatment of solid cancers, would you delay it's approval on the technicalities you believe are flaws in the trial.

I believe the results speak for themselves regardless how they're arrived at. It was really the German's who saw the benefits and got all the regulators to make the change so all entering the trial got DCVax-L, frankly if the regulators really wanted to act dynamically, they would have approved the vaccine then, but production would have been by clean room methodology for years while the FlaskWorks unit was being upgraded and approved and mass produced.

You tell me, would you not approve the vaccine knowing it was saving lives because of your belief that the trial should have been done differently.

Gary

[Extremist223]

DCVAX Approval for MGMT Methylated Tumors Irrespective of Tumor Location

Damn!!! Your stock REALLY popped $NWBO



"Christttt."

"Yeah he REALLY needed to come to the message board and tell his side of the story."

Hahahaha I called National Security about China USA and you are on this board getting the facts wrong. You should check my profile out.

Anything to get even one share sold out before this pops. That's what an Inventory MO'ASS problem is. Can't tap it, until you take the whole thing.

Live the Night Shankin' Shine-ease

[GPha]

EDITED
Quote:
I worked in biopharma world for over 20 years including on the team that developed and launched the most successful drug in history (at that time).

I highly doubt this statement obviously you are not the only one who worked in biopharma I'm a PharmD graduate and got the highest scores in different exams in this field I've been involved in different areas of this field in Private, governmental, and as a researcher. I've supervised a few RCTs in different clinical settings and clearly, you have no idea about what you talking about. Regarding your working in your drug discovery either you are a technician or a lab specialist with no knowledge in the clinical settings nor involved with executives. I've improved, supervised, and launched many products in the market due, to my higher education and expertise in drug delivery, especially biologics. With all due respect, you are a guy who tries to give us vague useless background to justify his reasoning.
Just one more thing if you don't believe there's an unblinded pharmacist that can identify who got what. check this document from FDA.

Quote:
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products" rel="nofollow" target="_blank" >https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products[tag]Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
[/tag]
And I quote from the document:
Quote:
FDA does not require patient-level maintenance of blinding at the time of disease
recurrence or progression. Unless there are no available appropriate treatment
alternatives, FDA recommends unblinding only the patient and the investigator at the
time of documented disease recurrence or progression by an objective measurement or
measurements to ensure optimal patient management. If sponsors intend to maintain
patient-level blinding when disease recurs or progresses and there are existing available
treatments, the informed consent document should acknowledge the risks of this
approach, and the protocol should include justification for the potential added risk.

I hope you understand PATIENT-LEVEL Who does identify them? because they don't unblind the whole sample.
EDITED hope this one don't get deleted