Replies to post #583901 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Using Bluebook examples is futile for a particular trial. Useless for drawing any conclusion.

The best GBM trial data in history is given in the JAMA article. Until the JAMA article is understood, confusion in the post remains. The JAMA article is not Bluebook material.

[hoffmann6383]

Correct, it's a done deal once the BLA is submitted:

$NWBO's chance of approval with a submitted BLA:

9⃣8⃣.4⃣%

(Data from 2011-2020) pic.twitter.com/7rrz6x9VIK

— Hoffmann (@hoffmann6383) February 2, 2023

[skitahoe]

I understand that DCTH's unit is being considered again and some believe it will be approved this time. When I first heard of it I thought it had potential, but after attending a presentation on it that potential was clearly limited. Unless the company develops other chemo forms and adapts it to providing concentrated chemo in other organs I really don't believe it's potential is very great, even if approved.

We have the potential of working in many solid cancers, that's huge, but even if it only works in brain cancers, our potential is still well into blockbuster range. I don't believe the same can be said for DCTH. We did have a friend who could have benefitted from the DCTH device and treatment, but it is a rather rare condition and he's no longer with us.

Something we all need to realize is that in any cancer trial there will be deaths, the fact that DCTH had that isn't unusual, but if they attempted to hide it, rather than explaining it, they feed the distrust the regulators have with the developers. I'd really like to see approvals obtained far faster, cheaper, and easier, but in every case each use of the product would be reported in a Phase 4 database and actual use in the real world would allow both regulators and the physicians and their patients determine if they wish to utilize the product based on the experience of others with similar conditions. The database wouldn't identify the patient, but if the FDA wanted further information they would be able to request it from the physician. I believe such Phase 4's can find the problems drugmakers try to hide with payments made to some with confidentiality attached.

Gary

[Mionaer1]

Optune will be obsolet soon. Game over man.

[biosectinvestor]

1) making reference to a random trial that the FDA did not like without analysis is just a what about distraction;
2) I note you did not provide the full particulars of and FDA critique of the trial you referenced. So it’s pretty shameless to suggest the same will happen here.

It’s ridiculous to attempt to frighten people by just pulling random things like that out without a proper explanation. And the reality is, you have no idea. So it’s just a scare tactic. Oh yeah, great results are sometimes real terrible and there was a case of that … it’s empty nonsense at this stage.