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The ongoing Phase II is intended to validate the PEBEQ instrument used to capture "bother", and is not a critical path evaluation of drug efficacy or safety. The FDA COA process was running at 10 months for review of a full qualification package pre-COVID.
In theory, possible to commence a registration study before FDA COA acceptance, gambling that PEBEQ approval is on the cards, or alternatively, hope for mercy from an AdComm, should the PEBEQ prove inadequate. Long odds, given that it's taken years for the FDA to even countenance "bother" as a potential label claim.
I guess the confusion is all down to Jamie's chrono-dyslexia but with no pivotal study protocol registered, crystal clear that there is no "overlap".
hello dougie. this view is based first on the statements in the announcements of 5/8 20 and 24/8/20 (i think the wording is identical) stating that on the assumption that the trial (11) is sufficient to convince FDA that PEBEQ serves as an appropriate measure to support a label claim, the pivotal phase111 could commence in latter half of 2020. this has i understand been supported by statements made to bignose on enquiry that the intention is to run 11 and 111 in tandem (presumably in part). i have been sceptical about this as i also understood that 11 had to be completed before111 could begin, but apparently the company has been standing by its assertion about the overlap. i hope i am recalling things correctly, but no doubt bignose will correct anything which i have got wrong. we will have to wait to see what actually happens. as to your point about the length of trial i think its very common for laymen (myself included) to underestimate significantly the time it takes to get trials going. even though this is a mall trial it's being conducted in difficult social circumstances, but perhaps most significantly they will have had to overcome the obstacle that it's probably not the most appealing trial to be involved in. its not a life threatening disease and tbh is it the sort of trial you would personally want to take part in? so i think there will have been recruitment difficulties, which is why i am pleased that they are largely on track time wise. just my thoughts and as always happy to be corrected or to hear other views.
Dougie
Stop being so lazy and read the announcements rather than coming on here expecting everyone to do your work for you. Read the operational update on Fortacin Aug 05 where it explicitely states phase 3 could start in the latter half of 2020. Which is before the end of the phase 2 validation study at the end of Dec 2020 (now jan 2021, although phase 3 will still have started before then).
running phase 3 parallel with phase 2? i have not seen that anywhere nor did i think that was even possible?? can you elaborate please. thanks very much
evening bignose. good news re FDA trial.thanks for posting.agree that there may be light the end of tunnel.very much hope thy are starting p111. still find this aspect very odd, but as you say they have referenced it twice so fingers crossed. as to the wider question, i doubt they will actually try and sell off fortacin. bit like selling the golden goose just before it starts laying, but who knows.i just don't see them getting an irresistible offer( or indeed even a mildly tempting one at moment,until positive news re OTC in europe or FDA approval). could always be wrong .that said i if the DLI deal does through i certainly expect further deals/developments in that area.as you say its obviously an area of particular interest to mellon,but also because it doesn't make much sense just to have DLI in the "portfolio". you can see from the square one news how all these little companies need to tie in together to gain traction etc and to maximise potential. could be wrong on that score as well of course.
The last patient was admitted at the end of Sept. If they have started and are progressing the phase 3 in parallel, which I have no doubt they are since its been ref twice in the last announcements, the company is still moving ahead nicely to eventually deliver. I can see the light, I can see the light............................Please don't turn it of just yet....lol
how has it taken till now to finish the recruitment phase? unless i am misunderstanding the trial process.
Yet it still dropped by 0.6 odd %. Certainly day traders selling into the slight rise and pulling it back down.....
And after lunch more buying interest !!! has it suddenly clicked re my previous post ?
Extra Extra, read all about it.
The FDA-Gov website has been updated. obviously the last participant has been enrolled given its now Active and not recruiting (top rhd red box). Estimated completion now the end of Nov with study completion date at the end of Jan 2021. one month on from the previous posted estimated and completion dates (no point in updating just for a month unless pretty confident it was coming to an end). Looks very much like there is light at the end of the tunnel and probably why the recent options announcement....in preparation ? https://clinicaltrials.gov/ct2/show/NCT03578783
Could they be getting prepared to offload the product to release some cash and concentrate on the Longevity sector given its all JM can think about ?
Given todays downward start, it would appear the majority of HK local traders are not interested in keeping up to date on the FDA progress, although the large isolated buys in the last few week could indicate one or two are (possible insiders) ?