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Following on from a number of messages yesterday regarding FDA approval I thought I should post a response I received on 18th december from Al on email:
question 1
I just have a quick question which I hope you are at liberty to answer. You mentioned that arm 2 of the AVA6000 trial is still due to finish in the first half of 2024. If we’re having 3 or 4 12 week cohorts then would I be correct in assuming that the plan is to run these concurrently (maybe assuming a two week tolerability period for each cohort)? Otherwise we’d be looking at a minimum of 36/48 weeks if they run in succession.
Answer 1 :
It is much quicker than that. There is a period after dosing (2 weeks) during which the first patient is monitored for DLTs. Then the next two patients can be treated concurrently if they are available. They then have a 2 week DLT period. The total for each cohort is less than 2 months before the SDMC can review the data and sign it off to proceed to the next cohort. As a rough guide you can see that the 5,6,7 cohorts in the 3 weekly study took 8 months – and we put more patients through those cohorts than 3 to get more data. So, we should expect 3-4 cohorts of 3 patients each in the two weekly to finish by the half year – depends on patient recruitment of course but very doable.
Question 2 "has the arm 2 part of the trial been approved by the FDA or is this still pending ? if not then would approval be communicated?"
Answer 2 " yes we mentioned that in the RNS (13/12). By the way - the FDA don't "approve" in the same way that MHRA proactively approve a protocol or amendment. The FDA has a period of time to put a stop on it but at then end of that period time you just get on with it if there hasn’t been a stop put on it. Amounts to the same thing I guess. Anyway, we’re screening patients in the US now for the two weekly study.
hope this helps
Yes nice posting guys …wasn’t expecting the detailed answers but obviously comms dept doing their bit … the extra detail really helps mitigate some of the ambiguity … I feel we are certainly in for a more rewarding year in 2024 so many shots on goal just a matter of time now …all the best and happy new year all
SB I wonder what information they have to disclose to comply then ? this is what I can't get my head around ...if they have to disclose details then you cant do it half hearted surely ? they will need to announce fundamental details which could impact the markets
As soon as finance sorted (which is only a matter of time now ) i agree the breaks will be off - if he did go down the dilutive route they should prioritise existing shareholders like last time provide a discount and I don't think he would have any problem getting £30m raised to see him through....as we all know there was £14m worth available not so long ago and we are much further a long.....
If someone two weeks ago would have said we are going for fortnightly dosing, phase1b is shortened and will run in parallel with c7, provided certainty that c7 is the final one, still no mtd and a significant reduction in tumour size in a patient you wouldn't have believed it.....and phase 1a data all being released this year ( in circa 10 weeks time) yet here we are at the same sp it was 3 years ago.....all we need now is a little more patience.....the only frustrating thing for me is the disconnect between the sp / risk ...those of us that have been holding for nearly 3 years now with that opportunity cost and yet anyone can still buy in at these levels given the knowledge we now have is pretty incredible....
totally agree ripley onwards and upwards from here with money in the bank until mid next year and efficacy date will be out well before then....on national news treating STS...whether it a licensing deal or partnership or takeover we are in a great place