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Dougie, the Phase II is not a measure of Fortacin efficacy as such, but to establish that the PEBQ questionnaire can accurately capture subjective perception of the degree to which individuals are bothered by PE and after treatment. You could validate the PEBQ with any old knob spray or PE treatment.
Let's lay out the risks: Fortacin gives some degree of perceived improvement, in most men, most of the time, and the study endpoint is set at a low bar. So, all good there. On the obverse, it's a very small (and under-enrolled) study, with a short treatment period (1 month). Former obviously squeezes statistical analysis and confounds result stratification, latter means only a small number of sexual encounters over baseline and no time for subjects to get familiar with application.
Historically, patient reported outcomes have taken very big numbers (usually with a consortium of interested companies involved) and years to achieve validation. The FDA is supportive of "patientcentric" outcomes, but there may simply not be enough in the full package (PEBQ non-clinical plus clincial validation) to make a call on this.
Binary outcome, can't help but feel odds are somewhat less than 50%. Options on failure would be a larger study, or plunge ahead in the hope that an FDA AdComm can be persuaded, although after a decade of FDA discussion, this would not end well.
that's a very fair point dougie.im not really sure how the "bothersome" questionnaire aspect plays in all this (it's emphasised as being necessary to demonstrate its acceptability as a proper measure,but i assume that's the next stage after these results), so if i had to bet i'd bet in favour of good to acceptable results. would like to see it in black and white though.
Has fortacin ever had bad results in terms of the effect of it ? I can’t see why all of a sudden this would be the case so I’m quietly optimistic things could turn out ok here.
evening heimdal.interesting figures re VRX,thanks.just shows this really was free money.i still can't understand how they have got the placing away at this price without crashing the s/p but they have and all well and good.new man starts formally next week. personally i do expect another investment in the longevity area ,although how soon is anyone's guess.agree that it doesn't make sense to change the branding if this isn't the intention.i just hope it isn't because they have lost confidence in fortacin or are aware of less than good results from trial.let us hope for good news next week.
Agree Italian, positive promotion. I also noted it on Yahoo Finance.
Copper in recovery mode and VXR up 3.5% today to 72.5c, as such we have already made HK$12,900,000
in profit on our new 8c (1:7 entitlement) shares. Not bad.
A new BUY recommendation by the HK Bulls has just been issued on 575 RPG after market close.
After trading sideways for the past 3-4 months within the narrow bollinger bands it might be time
for a breakout at long last on solid FDA news.
A few days ago Young.AI was updated again. On the Apple App Store a total of 51,237 users is noted.
It will be interesting how this app will pan out, hopefully DLI will start generating some cash flow soon.
I wonder if further investments within the Longevity sector will be on the cards in 2021. DLI came out of the blue
and more deals might follow. Changing the company name for just DLI does not make much sense to me.
Next week will be very interesting. I expect a Market Update on FDA progress and potentially also some
news on the VXR 1:7 subscription (total VXR holding now valued at HK$116.5m), EU, Taiwan and DLI.
Heimdal
you can find the press release on the regent newsroom section(apologies if already seen).it doesn't add anything and is poorly written in places (why can't they employ someone with a high level command of the english language to proof read these things.perhaps it reads better in chinese),but that said it's still a form of positive promotion.usual rubbish about returning monies to shareholders etc.its all about the trial results now imo.