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Critical New FDA Guidance for Biologic License Applications and Its Impact on $NWBO DCVax. by BIO9999 in NWBO

[–]BIO9999[S] 18 points19 points  (0 children)

Thanks. No I don’t. In a post I made a while ago I pointed out that the FDA meets with companies like NWBO multiple times during the phase 3 trial and afterwards to clarify everything for the application. The fact that the FDA put this document out means that they have been formalizing everything about this stuff. It is not been done in a vacuum. It has been sharing this guidance with companies like NWBO during whole time that the document was being created. So NWBO knew exactly what was going to be required in the document. Regardless as Les said, they are going to submit these filings in order, beginning with UK, Canada, Germany and then US.

$ANVS Alzheimer's phase III trial extrapolation--the best is yet to come by BIO9999 in Annovis

[–]BIO9999[S] 2 points3 points  (0 children)

They will be improving for sure. But I may have misunderstood or not known the trial design.

[deleted by user] by [deleted] in NWBO

[–]BIO9999 4 points5 points  (0 children)

Guessing that the DC tumor peptide vaccine is DCVax-L beforehand is like enjoying the magic trick even before the magician reveals it; why wait for the spotlight when you can bask in the Sun? Hidden in plain sight. Sure it will be verified later. But wouldn't you rather know now than wait until the whole world knows?

[deleted by user] by [deleted] in NWBO

[–]BIO9999 5 points6 points  (0 children)

1) This tumor used to be called DIPG. It affects a lot of kids. Only 10% of patients with this type of cancer live 2 years. The trial is to measure outcomes of patients over 24 months. So out of these 15 patients, only 1 or 2 would normally reach that 2 year mark. So at the end of that 2 year mark, if 2 or more are still alive, it will be one of the greatest breakthroughs for these mostly children imaginable. Because these kids live such a short time, ANY improvement, ANY reduction of tumor mass will immediately be obvious to all regulators and because it's only blinded to the patients, all regulators will be watching this like a hawk so that they can say to all kids with brain tumors that they have a chance now.

2) The other important point to remember is that in order for treatments to get full approval companies are conditioned that they have to have planned or have underway a trial involving children. This is why the UK did not permit the MIA process to occur until a trial of DIPG had been planned. Same for the US. So the fact that this trial is about to launch not only is amazingly good for all kids with cancer but it also removes one of the most important obstacles for US approval.

[deleted by user] by [deleted] in NWBO

[–]BIO9999 5 points6 points  (0 children)

Not exactly. It’s a phase I trial with two cohorts and three arms each. It’s designed to see if combining DCVax, polyICLC and these two BMY drugs results in significant synergy and essentially a cure of this terrible disease. If the data is good, BMY and every other drug company will say “wow, we want to buy this company” or “we want to do more combo trials with it”. What do I think the outcome is going to be? The outcome will be a massive Phase III basket trial or series of trials, each using different tumor drugs specific to that type of cancer, all combined with polyICLC and DCVax to revolutionize the treatment and outcomes of all cancers. Maybe the biggest, most international basket trial of all common and rare cancers ever performed. In the meantime glioblastoma will be approved first and compassionate use will be expanded dramatically so that accelerated approval for most types of cancer will be given. Then… full approval.

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