Replies to post #708750 on NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

Per the FDA:
Sponsors should finalize a study protocol before initiating the externally controlled trial including selection of the external control arm

I'm not sure what part of proper trial design includes generating an ECA after the fact and changing endpoints on failed primary. That is 100% BS. Just design a new trial properly and run it. Keep it simple folks. Oh i forgot they are broke because they fund the CEO's CDMOs...and that is the primary objective, and it isn't actually bringing drugs to the market. This company is 100% BS.

https://www.sec.gov/enforcement-litigation/administrative-proceedings/34-87281-s

NWBO disclosed in nine of the last twelve fiscal years that it lacked controls in place, including those surrounding related party transactions, to ensure that all material transactions and developments impacting its financial statements were reflected and properly recorded

https://www.businesswire.com/news/home/20180220006077/en/Cognate-Completes-Management-Buyout-Raises-Growth-Capital

LP sold Cognate for $$ in her pocket

https://find-and-update.company-information.service.gov.uk/company/08717711/filing-history

LP is getting NWBO to fund her privately owned ADVENT (Toucan aka LP). But oh yeah this is just a contractor that NWBO funds completely. cough cough wink wink, keep hurling the insults and name calling it becomes you Bharm.

[drugrunner]

Nwbo Already negotiated with the 4 RAs to change the endpoints

U are attempting to cloud the waters again with more FUD

[biosectinvestor]

Nothing you write is the law or even a regulation. Guidance I have shared with you repeatedly, is not the same as a hard rule or even regulation. The FDA uses it only as a “guide”.

They do give reasons and if you talk with a regulator and come up with a meaningful and excellent way to address the issue any guideline is intended to address, they tend to have an open mind if the result is a benefit to the public and to everyone involved, which is the case here.

In a previous post I explained how that worked with the ECA. The regulator has a mission to reform from formalistic ideas that are not only impractical, but delay cures and beneficial treatments from reaching the market just because someone in 1950 thought rigid formalism in such studies was the way to go. They know better, hence the approval to change the trials measure to its secondary measure, and to allow the ECA when the regulator had imposed a crossover to address issues of ethics. The ethics issue is actually addressed in their article in the subject of ECA’s by the head of the division that will make this decision, specifically in the case of deadly disease like brain tumors. They actually said it out loud. But shorts cannot hear or read when their interests are contradicted by a regulator.

Hence also Congress charged them to reform in the 20th Century Cures Act, and they have various, well known efforts to effectively transform these processes and maintain an open process that focuses on results, not on false notions of process that get in the way and delay cures.

So, yes, NWBO used a blinded, external, expertized firm to create that ECA, and there were literally no other trials to look at than the ones they considered statistically and, as blinded experts, “prospectively”. They looked at all the most appropriate and best run such trials that had control arms like this one, then they did immense and careful statistical analysis to ensure they were not just comparable, but that the results had very, very little potential for any difference whatsoever when the results were applied after the fact, after they had created their ECA model. They went far beyond what would typically be done prospectively and statistically, typically, and yes, because they could, and this was done by experts in epidemiology and statistics at University of Chicago that swore by affidavit that they were blinded, that they only looked at the prospective trial protocol and these other trials as well, and then upon unblinding, they applied the ECA they had created. This was all done before unblinding. Therefore, the requirement to avoid a biased, retrospective ECA was met. However, I will point out also, regardless of the rigidity you suggest, the FDA often not only allows, but even invites and approves drugs that do, in fact, retrospectively look back. If you read Adam Feuerstein, supposedly that is a no no, but the reality is, they frequently do things that shorts and shirt writers insist, not only doesn’t happen, but that they do not complain about because that would highlight how frequently they lie.

Further, the FDA has approved drugs for cancer and for brain tumors that are far inferior to this one with far more flawed data for even brain tumors, simply out of a concern that there be options to manage symptoms and improve quality of life, which was a result here for virtually all patients. This is the first trial in many decades to show a systemic drug that creates a survival benefit on its own, and when used with a stimulant, can almost completely change the nature of the disease for a large percentage of patients. And this drug does all of that while also improving quality of life and though it is all made up front, on a monthly basis, over the time of likely survival the cost is comparable or less than competing drugs when they launched, and n most cases substantially.

A regulator would NEVER ignore those things as you do. Never.

You, on the other hand, can write on bulletin boards, social media and maybe even articles for publication. But it won’t change the facts at the end of the final day, and that is all that counts.

Previous post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174821424

[antihama]

The IND not including an ECA is not a biggie. INDs are revised all the time to include new information.