I agree with this view and wanted to add to it that regulators granting DCVax -L approval in EU, US & Canada for GBM and other types of brain cancers would ensure that manufacturing capacity has to meet demand, certified, tested by regulators and ready when the approval is publicly granted. You would have tens of thousands of patients lining up for the vaccine after an approval and if production was not ready to meet the demand you would have failure at all levels.
The Sawston purchase and build out, 32k square foot expansion at Cognate, expansion at Fraunhofer as well as King's $2m build out in UK all happening around or after the partial screening hold of new patients is a telling sign in my opinion. This is the most important part in obtaining regulatory approval because if you cannot effectively produce the vaccine to meet demand it would be a major failure. Many here on this IHUB board have researched this information via their due diligence otherwise we would not have heard much about it as well.
We will find out in the very near future as this international Phase III trial is reaching its primary endpoint. GLTA Longs!
Great post Doc.
I think given the approval in Germany of the Phase II using DCVax-L, in a combination therapy, it kind of shoots a hole in the argument that "leukopheresis complications" would be the reason. It just does not sound right to me, given the new approval. I think it would be a different product, substantially if the entire approach had changed in the interim. Of course, I could be wrong.
And you look at the Car-T therapies, for BLOOD cancers, and which require draws... from extremely sick patients with blood cancers... and this theory also does not fit to me, in that context.
I think the halt had a German ethical component to it, as I've discussed elsewhere, related to having a placebo category of patients, with what appears to be, to the doctors and patients, I suspect, a patently obviously effective treatment. Purely speculative, but consider the Nuremberg Code. Germany had already granted the Hospital Exemption. The Germans are very sensitive on these kinds of issues given their history. Also, I could be wrong, but that's the only thing I can come up with that explains all the circumstances as they are, and the lack of an explanation. As you point out, "everyone is living longer". That's a big key, I think. The lack of an explanation, from the agencies, makes the reason for the secrecy, along with the continuance of treatment, very complicated and interesting. Why would agencies keep it a secret if something in the protocol created either a safety issue, or made patients less capable of fighting their cancer, or resulted in a futile treatment. None of that makes any sense whatsoever. Add the subsequent approval for the new trial, and you've goat a very unusual set of facts that suggest to me that researchers and others, including Merck and the local regulator, view DCVax-L very positively.
Again, speculative and I could easily be completely off here.
