Replies to post #158652 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I am not discussing any arm. The FDA allows for expanded access when patients apply.

The FDA has two programs for compassionate use.

The original version: Individual INDs.

This allows somebody to file with the FDA to treat the single patient. Flexible, but obviously paperwork is a bot of a bitch

The newer (circa 2007?) version: Expanded Access:

The company files a single IND with the FDA that covers patients meeting certain requirements. Once the FDA approves this, and patient meeting the requirements can be treated.

The current compassionate access arm that was being discussed is listed in clinical trials here

I do agree with you that there look to be some patients treated on the "individual" program. And I have no clue how it works ex-us

[biosectinvestor]

So again, on the short theory, that keeps getting reasserted as if it is fresh, fresh, fresh, though it is stale as can be...

You have two things that mitigate against it being likely:

1. They lost on a motion to dismiss, after amending their claim, and did not refile... on a case for which their theory was the key presumption for making a securities law violation. A motion to dismiss generally presumes a plaintiff's case is true as it has been pleaded, but you need to have just a small smidgen of some possible evidence that your claim is vaguely real. They could not meet the LOWEST standard in a federal court to proceed. We all know from the multitude of baseless claims in courts, that to not meet such a low standard, and not file again, means they failed completely to make their case even to the slightest degree when subjected to an actual standard of evidence, though it is the lowest required in a court of law. They can only meet the level of evidence required to create false controversy on bulletin boards, blogs and in rhetorical hit pieces that are examples of very poor "journalism" and that show a failure to even comprehend the basic science involved.

2. We have at least one known example, possibly others, where the FDA approved a patient's compassionate use of DCVax-L in 2016, and no evidence of a requirement of disclosure of a failure or a futility determination. That seems very unlikely given the facts that shorts allege unless the facts they allege are not consistent with the reality.

There are many other bits, but I look at these details and each time a short makes an argument, can only roll my eyes at their determination to keep raising the same points over and over again, despite the above, particularly the first item, but especially now, the 2nd detail. In the fact-based world I inhabit, the FDA is a responsible agency that makes fact-based decisions patients and their doctors know the relevant risks, and does not allow people to be ripped off if a trial has failed or been found to be futile - and even if there were some profound ambiguity, full disclosure would need to be provided. I don't see any patient proceeding based upon the facts alleged by shorts or getting approved.