I agree with Druggie that the BP's provide much of the FDA funding and therefore they have a bias toward their products. They will approve good products from both BP's and biotech's, but if the products have some doubt, it's the BP's product that will gain approval while the biotech's product requires additional trials.
When you see drugs where advisory committees suggest more studies, but the FDA approves, you can bet they're coming from a BP.
I do believe that our vaccine would gain FDA approval if we had the commercial production facility to make it, but that awaits the EDEN being ready. Because of Sawston's manual capability, going for UK approval is the clear choice for gaining approval before the EDEN is available. If other European nations, or Canada, believe that Sawston can meet their initial demands we may see additional approvals before the EDEN is available, but unless other resources can be brought to bare, I can't see the supply being close to the demand.
Over the years I'd be curious how many patients have had their tumors properly preserved and are still viable for receiving the vaccine. The priority on who will receive it first will be rather interesting. It will also be interesting to see if vaccine in the compassionate use program will be available after UK approval. as I see it, with UK approval it's available to their citizens and it's provided by the Govt. in their healthcare system, but I don't believe any foreigner could even pay for it there. With the compassionate use program I believe it's available to all those willing to pay for it, and that's included many foreigners.
Gary
