Folks, I got a date wrong on the third approval possibility, so I'm reposting it with the correction, thanks to VL. But it doesn't change hypothetical approval meeting dates.
What are the possibilities that DCVax-L will be approved for new GBM and recurring GBM at one of the next four meetings of the UK’s CHM (Commission on Human Medicines).
They meet on these dates:
May 30-31
June 27-28
July 25-26
Aug. 29-30.
But which is most likely approval day?
Many have already discounted May 30-31, but I think it’s still possible. First, It fits with our submission deadline date of Dec. 25, 2023. May 25 is exactly 150 days from this deadline, but it’s a Saturday, so if UK’s CHM wants to move quickly on DCVax-L, it makes sense that they would approve it at 149 days, rather wait another month for when the commission meets next. Secondly, we received a “validation confirmation” date on May 7th, which just happens to be 2 days before we hit the 80-day completion of Phase 1 of the regulatory process, if you believe the clock started on Dec. 20 when we submitted our application.
But we have since learned that the clock starts when we receive “validation”. Our application passed validation on Jan. 24th, then our validation was “confirmed" on March 7th. The two different validations reported in the quarterly have created some confusion and speculation. I think there is a possibility that the second validation may represent when our application completed Phase I where we received NO request for info from CHM, which means NO need to stop the 150-day clock. Confirm means to check again. That fits with the idea that the first validation was quicker and less thorough and was followed by a more complete examination of the MAA, which ended in the March 7th confirmation and perhaps the end of Phase I. This hypothesis only works if we assume CHM ignored their very late (IMO) Jan. 24 validation and moved quickly to study our MAA.
The second possible CHM meeting on June 27-28 coincides with the first validation date of Jan. 24. 150 days out from Jan. 24 is actually June 22, another Saturday and 5 days before the start of this meeting. If we follow the 150-day law to the letter and believe there is no clock stop for answering questions, then this is the likeliest time to expect the UK to make a decision on our application.
The third possible CHM meeting date, July 25-26, somewhat aligns with the possibility that the clock started when our validation was “confirmed” on March 7th. 150 days out from that confirmation is actually August 4, a Sunday. If CHM members wanted to move along our MAA, they could choose to make their decision on July 25-26, which is 6 days before the 150-day review ends which includes a weekend.
If they decide not to make a decision on our MAA a week early, they would have to wait almost a month until their next meeting on Aug. 29-30. I don’t see that happening unless they are trying to give our automated system another month to complete validation.
None of these dates address the possibility that NWBO may need to stop the clock to respond to a request for information letter from the UK. If this happens it could add 60 or even 120 days to the approval process. I think a clock stop at this point is unlikely, given the comments by Les and in the quarterly. Both were very bullish comments. NWBO has been very cagey about appearing bullish because so many negative shorts have attacked the company and even reported them to regulators when they’ve committed lesser infractions. If the clock started on Dec. 25 or on Jan. 24, in both cases, we would have completed the 80-day phase I long before the time we received the quarterly on May 10 and heard Les speak on May 9. If we accept the March 7th date for when the 150-day clock began, we would have been about 2 weeks before completion of Ph. 1 I believe the rules state that companies receive a request for info only after Ph 1 is complete. I think it’s unlikely Les would have been so bullish as to state “no news is good news” and the quarterly would have told us they had not changed a thing in our MAA if they knew the potential clock-stopping news was still in the future.
Of course, all of this assumes CHM doesn't set a special meeting for NWBO's application.
Bullish
