Replies to post #151057 on NorthWest Biotherapeutics Inc (NWBO)

[TiltMyBrain]

He expresses that the trial and technology is very exciting!

[Hspooner]

Thanks for the clip, but that tells exactly nothing!!

[CaptainObvious]

Interesting.. From the tone of that I got the feeling that it was about the company itself, not the trial or tech. He seems to stop himself mid-word saying "ex.." or something. Maybe he thought better of it.

If it was about the company, somehow I think that's better. Not sure why..

[flipper44]

Under that theory, the FDA must have stopped looking into the company. The halt was lifted.

[longfellow95]

Good spot.

But, I think this Professor doesn't really know.

It sounds just like the repeating of mischievous rumour.

And in any event, it is not the FDA's role to 'look into' companies.

Do we know if he is a site investigator for the trial, I wonder?

I think the possible issue regarding repeated leukapheresis as forwarded by aboobmove might be relevant here.

Though ,if I recall, Dr Bosch stated that, in practice, a requirement for a repeated leuk was rare.

[pgsd]

Hilarious. After all this time and supposed DD this is the best you can offer ? I will tell you what happened, the FDA looked into the company and this resulted in them LIFTING THE HOLD..Unbelievably funny but thanks for the groundbreaking and significant reason why all longs will now have to horry up and sell.

[monentum2play]

Doesn't say anything!

[VuBru]

AVI - Saying that the FDA is "looking into the company" as the reason for the halt is entirely uninformative in my opinion. This captures every possibility because the FDA clearly would not have halted if they weren't looking into something. Could be consenting or other record keeping inadequacies, manufacturing issues, failure to adhere to protocol, etc. If it was for patient safety, they would not have allowed ANY patients to continue in the study because they were still receiving the DCVAX injections - that did not happen. My understanding is that the FDA does not halt for lack of efficacy - they are willing to let companies spend their money on trials as long as they are safe. So, yes, it was halted for something but the fact that they allowed those in the study to continue receiving treatment and the halt was lifted indicates that it was not a fatal issue.

Regarding your previous reply, I agree that the lack of info on interim efficacy analyses is weird - did they choose not to do it and "save alpha" but just never said so? Cannot imagine an independent DSMB would do an analysis then lie about it because they did not like results (thought a DSMB member said they did NOT do one). In the bigger picture beyond design and analysis details, there seems to be something accounting for unusually long survival based on blinded data to this point.

[iwasadiver]

Since we're all throwing in: I believe he was about to say the FDA is "extorting" but thought better of it. It fits the tone of his disappointment that this truly innovative trial was being dicked with by regulators in the US. I believe he knew precisely what was going on and it wasn't about being upset with NWBiO in my opinion.

[Lykiri]

The BRAIN TUMOUR CHARITY:
in 2016 the Organization asked prof.Garth Cruicksand to give a lecture :

(NOT pro dcvax-l)

In 2017 the same Organization asked MD Keyoumars Ashkan to give a lecture:

"DCVax is important because because I genuinely believe that immunotherapy is the way forward for brain tumors because I think there's nothing cleverer than our own immune system to be able to cope with variations there […] brain tumors are difficult is because they are very heterogeneous, extremely genius, no tumor is the same in two different people even different areas in the same tumor are not the same, okay, and the only technology we have which can cope with that amount of variation is your own immune system. Why? because over ten million years it evolved to protect you against millions of pathogens, right […] what should we do? We should prime our own immune system to attack the tumor hence the individualized therapy called DCVAX. The reason I’m keen on that because I was the European chief investigator for this trial which we finished about I think three four months ago now we are waiting on follow up data."

link:

(PRO dcvax-l)

hmm, hmm, hmm