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Guessing here, but the PRO data will surely be presented in the context of an end-of-Phase 2 meeting, for discussion alongside the Phase 3 study design (and whether as a new indication, one or two pivotal studies are required), and other key issues (critically, satisfying the fixed-dose combination criteria).
The last release indicated that the internal statistical analysis and study report were done and dusted- it's not impossible that the delay is down to other elements of the meeting package. Rule of thumb is meeting takes place around 10 weeks months from submission, meeting minutes provided after 30 days.
completely agree bignose.no reason for delay over license talks,so if there is delay and there certainly appears to be, the reason must,imo, lie elsewhere.
I still do t see any reason to delay a submission on the grounds of license talks, particularly phase II, since the submission still has to be made and surely will not effect anything. The only possibility is if a license is sold outright, but even then it makes no sense, unless a licensee agrees to take over the complete approval process and given phase II has not been submitted could effectively be considered as the start. All just speculation on my part.
HK markets closed today for Mooncake Festival.
yes bignose.thought it worth a try,but also not surprised by response.all a bit puzzling.also just had email about thishttps://events.masterinvestor.co.uk/events/investing-in-the-age-of-longevity/?utm_source=Longevity+Contacts&utm_campaign=a388ea701d-longevity_DB_20180918_COPY_04&utm_medium=email&utm_term=0_cff1a605f8-a388ea701d-48849694&mc_cid=a388ea701d&mc_eid=c3ceb003f0 i know these events are a waste of time and basically money spinning self promotion,but disappointing nevertheless to see no apparent link or tie in to DLI.would have been nice to feel we were actually on the radar as it were.ok back to poms theory!
The.Italian,
Thanks for trying, although I expected as much. The guy is a real dcik. 2 day window now heading towards 4 weeks and no explanation. What a complete fcuk up this phase II has been from start to finish, and its still not finished. Over 3 years for 100 subjects. Really incredible.
morning/afternoon all.just to say i have emailed jamie today asking if he could confirm that the results have been submitted or provide clarification of the position.response received simply saying "any updates will be given in normal course by way of our announcements as published via the exchange and our website.so please monitor these".not sure what to make of matters now.is it indicative of a problem or some wider issue? who knows.if there is a problem i would have thought it would need to be announced in view of the previous statements,but these issues are never simple,so could be completely wrong.sitting and waiting again then.
I have given up thinking the company are making positive moves behind the scenes until the day an announcement stating so comes forward.. I don’t understand how we have not been notified regarding submission , what it could mean I can’t even guess
Although POM could be right, I’m afraid we have speculated far too often on what the company is or was doing only to be let down with a bump due to incompetence (no other word for it really). As such, I’m not going to get any hopes up on on what they are doing behind the scenes since it’s usually nothing.
afternoon bignose.i couldn't really argue against that.just hope we are wrong (could pom be right? not holding my breath).also been very quiet on DLI front,although that is not too surprising I'm afraid.
Morning The.Italian,
I think something is amiss. If they miss a two day window by 3 weeks when they appeared to be on top of it, what else could it be ?? They have to inform the market of the submission since it’s a major step in the approval process which has financial implications.
so another week passes and no news.seems very odd,unless they simply don't regard it as necessary to make a formal statement in view of the last one.personally i don't buy that,but who knows.
afternoon bignose. interesting thought,but like you i don't really see how that would be any reason to delay.yes if phase111 it would possibly make more sense,but not at this stage,imo.it is a bit worrying in view of the 2day window,but conversely they were so positive about the results that I'm inclined to thing its probably not serious.of course we are assuming they will notify when submitted,but i would have thought that was fairly certain.so as always fingers crossed!
Certainly a concern that the phase II results have still not been submitted 2 weeks after they were meant to be on a 2 working day window. And given how good they are meant to be, what's gone so wrong ???
That said, the only other possible answer other than a lack of paperwork (they have done it many times before) could be as postulated to me recently by POM that..... "Are the result being held back because of some impending US agreement ?"
Although It certainly would make sense in one way (why else is there a delay), I really don't understand why phase II results would need to be held back because of this as its surely time wasted. I would have thought it more likely if they were results from phase III, but they are not, so? If, however, they are held back because of this, then it could be very good for us all, although given the amount of previous speculation on events, it may just be, once again, down to incompetence ?
Anyone else have any thoughts on the matter ? Need to keep the lights on here in case we miss something....lol.