Member Info for bignose58

bunion

discombooble..............er
discobooby..................er
discumbumble.............er

I give up....... I cant say it and I def cannot type it.... :-(

Hoooorrraaahhhh :-)

AIMHO of course .... LOL

The.Italian.

Realistically there is a much larger study group, its called the E5. And although the FDA are choosing to ignore this study group since its not done in a controlled manner and in a laboratory, any feedback surely cannot be ignored. Currently there has been no negative feedback from users apart from better clarification on how to apply the product (feedback from Recordati). In fact doctors who have prescribed the product have already stated that its better than sexpected.

Even an FDA laboratory study of 100 or even 600 participants cannot compete with results from actual everyday usage by Joe public and the 10's of thousands that have already used it although It does just show you how ignorant and bureaucratic the FDA can be. European approval with already thousands of users and they think they will find a problem with it....otherwise why all the fuss ??? Other regions like HK and Macau are happy with the EU approval. So why not the FDA? It makes no sense whatsoever. And if China approves without the need, the FDA are going look complete d*cks.

Interestingly I recently read of a product that had been given FDA approval, but due to public demand over worries regarding the contents (most people are not chemical engineers and have no knowledge of such things, but go on media and word of mouth which can be all wrong), the product was taken off the shelves. I'm afraid I cannot remember what it was, only that I read an article recently on it. My point being that it all makes a bit of a mockery of the whole system on an already approved product already being used by thousands and I don't suspect for one moment an American is any different than a European, in fact most Americans are European anyway... n'est pa.

None of this makes any difference of course since the FDA make the rules, but it certainly makes them look stoopid.

:-)

We'd go bancrupt given its track record.

Anyway, we've got more chance of seeing pigs fly, thank goodness. Particularly since it is the year of the pig...oink oink.

Likewise pp

H-N-Y.... :-)

The.Italian

That is correct. My point being that we should be able to quantify some progress by seeing which ones come on line over the period. We are currently at 4/9 recruiting (44%).

Anyone seen the affect and even the effect on an SP when a change in CEO is announced..........

MTL up over 100%

Makes one think doesn't it.......................LOL

Product size used in the study:

PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine.

Which is different, but then does it really matter since the testing is on the product effects and as such the correct dosage would need to be correct. I could be wrong, but I am sure different data is used for the "to be sold can size". and surely the EU stability tests for either the 20 or the 12 dose can should more than suffice as a shelf is the same no matter where one is in the world.....LOL

MR

German study link below. If only Recordati or even RPG had read it they would have known exactly what to sexpect.... ;-)

http://tinyurl.com/ya8oguh2

Incidentally I sent a copy to JG, who obviously had not seen it since he forwarded it on to Recordati who really should have already seen it !!!!!

The.Italian

Study Type :Interventional (Clinical Trial)
Estimated Enrollment :100 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:Treatment

A Pilot Multicenter, Randomized, Double-Blind Study Comparing The Proportion Of Responders to PSD502 and to Placebo Using the PEBEQ In Subjects With Premature Ejaculation.

Or you could just visit: https://clinicaltrials.gov/ct2/show/NCT03578783 and read about the study yourself. ;-)

Or was there an other post deleted........so many have gone, that I cannot remember what I typed and uploaded and what I didn't........ AAARRRGGGHHHH.

Morning sldmr

Errr I don't think so.......All subsequent posts are still as they were.... I think all these indiscriminate unreasonable deletes are making us all jumpy......BOOH...WhhhAAAAA...Run away...run away...........

MR

Given that, as you state, the US is approx. 5 times the EU and they can advertise, why on earth didn't they do the US first ??? (particularly since that's all they kept going on about in presentations etc.) Surely the German study would have been widely known about and as such the advertising in the States would have been worth its weight in gold. And even though limited to the States, the ROW would have picked up on it quickly through media channels with no limits. i.e laying down a good foundation.
.

If anyone is interested the following is the current status of recruitment:

Locations:
United States, Alabama Coastal Clinical Research: Not yet recruiting
United States, California San Diego Sexual Medicine, APC: Recruiting
United States, Florida Avail Clinical Research: Recruiting
United States, Indiana First Urology: Not yet recruiting
United States, Louisiana Regional Urology, LLC: Not yet recruiting
United States, New York Manhattan Medical Research Practice: Recruiting
United States, New Yotk Premier Medical Group of the Hudson Valley: Not yet recruiting
United States, North Carolina M3 Wake Research, Inc: Recruiting
United States, Tennessee Volunteer Research Group: Not yet recruiting

Montezrevenge.

Lets hope so. it would seem the logical move to keep all contracts/agreements with PLE so RPG can continue to function. This of course throws the idea of a company wanting in on the HKSX out the window.

I wonder if all there agreements include a clause about them staying in place even if PLE were sold on.

Well, that last post of mine re LA was removed pdq. I don't understand why since I wrote the same stuff a few times since the summer of 2016 and they were not removed.

Anyway, as I wrote. Excluding China, which wasn't even to be considered, the ROW licenses were at heads of terms in late 2016 (although anybody's guess which one/s) and still nothing. Not even anything to say why there were downgraded back to "at an advanced stage", which can mean nothing or something given how long its all taken.

Agree maybe a US pharma is also in the melting pot, but why "at heads of terms" only to go backwards.

Apols.

That shd have been a dressed to Matt :-O

Sldmr,

There will also be announced in a few weeks another profit warning. I dont think the E5 sales will make much of a dent in that one either. Unf the payments will be taken into 2019 earnings, but hopefully no more profit warnings after 2019 ... ;-)

Timmmbbbeerrrrrrrrr.........

It's now worth less than before the deals........ It would appear the BioWorld article seems to disappoint.....Maybe just early days...... LOL