“Besides waiting for combo results as you suggest as one possibility, are there other there other reasons to deliberately slow play the submission that might be more commercial than regulatory in nature?”
—The other reason I have mentioned is around red tapes or bureaucracy at the MHRA. Perhaps they don’t have full buy in from all the stakeholders or a new guideline document that addresses our complex trial is in the works and NWBO’s consultants have advised them to hold off on submitting until they come online? I mean some of the UK politicians still continue to lobby and beg to the parliament around increased funding for GBM, personalized vaccines, encouraging ECA trials, etc. So that to me indicates that some sort of political blessing is still needed to get DCVAX-L approved and reimbursed all the way.
“When testing a new manufacturing device like Flaskworks, does it make sense to apply the modifications to all devices for all treatments under the Specials Program, or just a small percentage? I just can’t rap my head around why there is no Specials Revenue because Flaskworks is being optimized.”
— small percentage. But different tests will have different requirements. For instance, we do some biocompatibility tests as part of our regulatory process and there are several tests that require us to have 9 devices churned into a mixer for 3 tests; 3 for each test. We often argued why they would need 3 per test because one itself gives them enough volume to run these tests multiple times, but we have not been successful!
Having said this, all the excuses around connecting drop in specials revenue with optimizing Flaskworks is just BS by social media army. If it was true, the management would have brought attention to this point and established a link between the two specifically in their 10Q. I’d think it would be received very positively by the market that they are making meaningful progress with Flaskworks certification and that would help justify that the number of patients they treated in Q2 have not dropped (but in fact grown from previous quarter). Makes no sense why they wouldn’t highlight this in 10Q, if that was the case.
