I feel like I have to re-repeat re-re-again that IMUC can get accelerated approval and the data will decide. Because of the manufacturing process some observers do not think so, and have told everyone on Earth.
If the data is strong then there will finally be a treatment option for some people with this most lethal cancer. That is what accelerated approval was made for.
What about the manufacturing process? If the data is strong enough the FDA will show flexibility like they do in most orphan drugs. It's not like they could not agree on a working manufacturing process when they have data from two clinical studies.
From the last CC (thank you Vanmaarsum!):
<Q - Ryan S. Martins>: Hi. Thanks for taking my questions. Just to follow-up on the manufacturing-related questions. Initially - so can you talk about what you will need to show the FDA in order to demonstrate comparability of your manufacturing process of the three different sites that you've used, and what you eventually do come up with for phase III for commercial and clinical?
<A - Andrew Gengos>: Thanks, Ryan. It's a complicated question. Let me try to give you a simple answer. When we moved from the University of Pennsylvania to include PCT for the phase II ICT-107 clinical supplies, we went to FDA an went through a brief process with them to demonstrate that we were using the
same process at both facilities. That's really all that FDA requires. But I think your question is sort of deeper than that. What we're trying to do witthe results of this Phase II trial and the assay work that we're doing in the context of manufacturing but also in monitoring patients in that trial, is show both that we have a consistent product lot to lot. Now remember, a lot
is a patient, in this case, so we had 124 lots in the phase II trial. So again, we're going to try to be showing consistency lot-to-lot and then we'r also going to be trying to show assay information about the vaccine that is connected to the clinical outcome in the trial. Those are the two essentiall key sets of assays, identity of the product and characterization of the response in the patient. Those are the two things generally that we'll be talking with FDA about in the end-of-phase II meeting in the CMC section. It's a lot more than that, but I think those are the two at the heart of you question.
Disclosure: I am long IMUC.