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Although you are now also involved with FUM, which I am sure you must have been watching, like me, for sometime, you didn't also happen to consider N4P?
I write this since N4P were also developing an ED product using a reformulation of Sildenafil (active ingredient of Viagra), although in Sept 2018 The Board identified that the risk reward profile to reformulate sildenafil to meet the required drug release profile was too great to continue and they since decided to close the generics division . They now seem to be spending their time and money developing Nuvec, a novel delivery system for vaccines which could be of use in collaborating with other companies developing C-19 vaccines ?
There certainly seems to be a lot of posts on the matter and the company has stated as such too. I see the share price is now heading North and could be a really good opportunity during the next few months if some of the other companies who mentioned C-19 are anything to go by (NCYT for example which has gone up 20 fold in a few weeks). NP4 still has a low market cap (6m) which is peanuts if compared.
I mention it here since it did have an ED product and the company is distantly linked to Dr Mike through, if I remember correctly, one of its employees who also worked at Pfizer. Interestingly Dr Mike did mention to me some years back that he felt the product reformulation wouldn't really be a show stopper since one could just take a Viagra tablet, crush it and rub it on the helmet to get the same effect...... :-)
Anyway, just a thought and maybe of some interest to you. It could also be of interest of a few others here too ?
afternoon bignose. yes did see that. tried to work out what was going on but got lost in the various incarnations of yoyo.anyway it doesn't seem to have gone down too well there, at least looking at the majority of posters . lot of disappointed expectations.now where have i heard that before! perhaps we had a lucky escape after all. does smack of chasing the next big thing. still possible i suppose that we might get something left field here, but meanwhile the relentlessly low volume continues. living in hope.gl
Well that’s a turn up for the books. Lorne Abony stepping down as CEO and getting more involved in Yooma or is that just Yooya with a lisp, it’s till CBD related though. Obviously some jiggery pokery going on in Jim’s stable. He’s made a bolt for the door and I’m not referring to him becoming a blacksmith....lol
Speculatively, will RPG soon make an announcement about some CBD investment using money they don’t have and will it just be another DBC debacle ???
Will be an interesting next few days or maybe weeks or just nothing at all... :-)
No we wouldn't because, as I stated, this information has not been announced to the market.
Yes, yet another F&%k-up since they reduced the time period by 3 months when 6 months into the study, then by the end of the year, we are having to wait another 9 to twelve months which was not announced until March ..... It beggars belief. It's quite obvious this was known before the end of the year (you cannot tell me that they didn't know it would take longer until after 31st December). As such, an announcement should have been made long before, irrespective of it being a closed period.
Remember the study was announced to start in July/August 2018 which I had confirmed by JG at the time by email. We were then informed several weeks later it was delayed to start at the end of Dec2018/beginning of Jan 2019, no reasons given. Its Nothing more than pure incompetence and total contempt for shareholders. The CEO needs to go and his huge salary given to someone who is more competent like maybe a 6 year old.
It was the same with the HK/Macau debacle. shareholders were informed on a few occasions that the import license would take a year, which finally took two years and we are now heading towards 2 years post license award and still no launch......WTF.
They obviously are walking around with their heads stuck up their backsides....... And these are meant to be professional people !!!
would we not see a better price than current if this was the case? what i dont understand is why its taken so long and then been delayed further again , taking corona out the picture as well.
Bothwell, good of him to take the time to answer, if only with the usual scripted waffle and with no relevance to the evolving US PE treatment market,
Out of pocket drug cost is everything in the US (lifestyle drugs are not covered by CMS and, if included on a health plan formularly, are top tiered). Romans and others flog monograph products and generic off-label SSRIs at low cost, no insurance hit and with minimum fuss. PE treatment acquisition cost is, de facto, now set at $3 a dose and may reduce on increasing competition. There's a crossover between consumer and professional channels in the US: monograph products such as Promescent and Pre-Boost, which needed only a few million dollars of investment to reach market, are already actively promoted to urologists.
RP's desperate gamble is that, on the strength of FDA approval, Senstend (or whatever the US name will be) can command a price high enough to leave a decent margin after DTC and professional promotion costs. Everything hangs on punters (who pick up the whole drug and consultation expense) being convinced that the premium over OTC knob sprays or cheap off-label SSRIs can be justified by it being labelled as reducing the "bother" of PE.
Point of correction, but US monograph product labelling can include treatment claims, specifically "helps in the prevention of premature ejaculation." Does anyone other than RP seriously believe that slapping "reduced bother" on the label will justify an 8 to 10-fold price premium? Just look what the absence of differentiation and comparator or post-market studies have done for European uptake and prescriber opinion. The continuing and meaningless comparison with the ED drug market is getting really old.
As to the defensive position, the PRO is copyrighted, but "validated" only in that the FDA have agreed that it can be used in a clinical study, which may or may not lead to submission of a full COA package. True, if accepted as a COA tool, it could be useful (although not essential) to a third party seeking approval for a PE treatment, but in reality provides no direct protection for Senstend/Fortacin US.
In the absence of patent protection, the product would have only three years market exclusivity on FDA approval, after which a generic version can be approved on the back of a single (say 20 volunteer) bioequivalence study, although the market, if there ever is one, is not likely to be big enough sufficient to tempt generics players.
But, nice that he's still on message when the reality is a stalled clinical study, no cash, major manufacturing problems, no sales in the most developed PE market in the world, and a disengaged marketing partner.
Oh and I stay since I believe in the product, which I am sure will eventually get approval and sell, however. I am a lot less confident regarding the magnitude of US sales as I was given the disaster in the EU. Even with advertising, I am sure there will still be a modicum of stigma attached, which is not even discussed in the last presentation posted in March 2019 after the EU disastrous sales were known.
That said, I have no concerns about alternate products since there should be more than enough sufferers willing to try the different drugs. One only has to look at the ED market and the number of different marketed drugs available, including generics and most, if not all, companies are still making money.... ;-)
We will get there eventually.......... hopefully, as Keith states, we will all live to see it even with the C-19 floating about :-)
That's all well and good, so why do they persist in not informing the market of these facts instead of allowing the SP to disintegrate. This is the sort of information the investor community needs instead of just stating 6 years ago something to the effect that discussions are ongoing and they hope to sign agreements in the coming months. if they can make announcements about a possible TO of Yooya which came to absolutely nothing, they can surely inform the market on the US license agreement progress in more detail...no ? .
The USA license discussions have been ongoing long before the Chinese one which, as mentioned before, JG stated categorically face to face in June 2016 that China was not even a consideration due to the beauricratical red tape. Yet here we are with an agreement in place !!!
The pi's still here, and there are very few now, deserve much better. Some have been invested for more than 10 years and not just by buying shares on the open market, which does nothing with respect to supporting the company, but purchasing during the early placings (note how the pi's have had their balls removed with respect to subsequent placings since TO). The company namely JM and JG are sending a terrible signal regarding only allowing those with funny handshakes to partake or to fill their own pockets. It was during the early days when the company desperately needed funds when the pi's stepped in to help. Granted, monies were also sought from larger companies which have now been bought out, but remember its the hard earned private money out of Mr Joe averages pockets which means much more than the likes of companies who just use throw away money..... imho.. :-)
And just as a reminder the following is extracted from the PLE 11th March 2014 announcement regarding the unambiguous FDA approval process: "Negotiations are at a more advanced stage with a number of potential marketing partners
and the Company is hopeful that an announcement will be made in this regard over the coming
months". Granted that is also followed by a statement "Given the nature of licensing talks, it is not possible to
determine with accuracy the timing of completing such agreements". However, the fact that they mention "advanced" clearly indicate that signing an agreement could have been pretty close, yet, nothing and no reason given. This is surely unacceptable. If the license talks had broken down, which obviously they had. Investors had a right to know where the company stood or now stands.
Regarding the price point sensitivity they wrote about that with regard to the 6 dose cannister and then with the 12 dose cannister which now turns out to be more preferable with the 20 dose cannister. So why not start with the 20 dose cannister and change, if considered financially viable, later ?
No, I am sorry but the company has absolutely nothing but contempt for share holders who are now suffering with next to no news and a decimated share price.
Nice to read some slightly positive news. I just hope that I live long enough to see this ‘money fountain’ start to flow in the USA.
They are in regular dialogue with the potential US licensing partners and are confident they will be in a position to sign a deal, should the board consider it appropriate, well in advance of NDA approval. Several companies have already done due diligence on their clinical and regulatory files.
Thanks for this bothwell, glimmer of light!! any news on timing of news releases to maybe clarify how things are going from them?
They have done price point sensitivity in the USA and it is well beyond that in the (EU). In terms of dominating the USA they have protected the brand by copyrighting/trademarking the PRO. No one can use it without their approval and without making a considerable payment for its use. No one will get approval without using this the only FDA validated PRO.
very illuminating bothwell.thank you.
It is important to remember that the single most important market for sexual health products is the USA. If modelled on the revenue from erectile dysfunction drugs, this will account for 65% of global sales. The whole of the EU is likely to be 12-15%. That is why they are persevering with approval in the USA, despite many obstacles the FDA retrospectively introduced e.g. need for disease definition of PE and a validated PRO.
The Numan products should be seen in that context. The USA is the key value driver for Regent stock.
The most important factor is that there is absolutely no peer group reviewed clinical data to support the claims for their delay spray. In fact it looks like they are “borrowing” claims from the Fortacin label. That indeed was the case previously with Promescent that used our clinical data on their website until they were stopped with a “cease and desist” notice. The reason is that they don’t work or have obtrusive side effects particularly penile desensitisation.
In that context, their website would be illegal in the USA as this type of agent can be sold as a “monograph”product as a penile desensitiser and medical claims ‘’......for the treatment of......” are not allowed by FDA.
I have just received a email back from Professor Michael G Wyllie and not from Jamie and Jim. In my opinion it is extremely positive towards fortacin and RP.
Bothwell, that was thoughtful of you. Not sure whether Numan ship to Hong Kong, but likely that they cover the Isle of Man.
I have sent an email to Jamie and Jim.
Not good, and certainly old, news.
I posted on this over a year ago with reference to men's health-focused US companies offering online consultation and PE, ED products over a year ago- HIMS, Romans and others. HIMS UK currently offers only ED treatments. Numans was founded by Sokratis Papafloratos (a tech investor), looks to be closely modelled on Romans. At 15% lidocaine, the Numan spray is not Promescent but some other OEM product
Very low barrier to entry (wholesaler's licence, a couple of minimum wage GMC registered box-tickers sitting in Estonia or Romania, someone to knock up infomercial content, packing facilities. Oh, and a website...). Business model revolves around building confidence in the brand sufficient to justify the price hike over getting Viagra Connect from Tesco or saving yourself £13 by buying Stud 100.
Context of last year's post was how Romans and others make a nonsense of RP's fanciful pricing (and desperate hopes) for the US. Including consultation, you can have a PE treatment of your choice (spray, wipe, off label SSRI) delivered for around $3 a dose, no expensive medical consultation or hit on your high deductibles medical insurance.
Romans offers re-badged Promescent and Pre-Boost wipes (both are also promoted to urologists, the latter by Timm Medical, a Plethora subsidiary once upon a time).
Rules on distance prescribing vary in Europe, but there are a few currently offering Rx and OTC PE and Rx ED products in several countries (Doc Morris, Zava).
thanks for all that. do i take it this is not good news?
That should have been....
And according to numan, 66% men in the UK suffer from ED and 40% from PE...... oh and they also make BBQ sauce.....LOL
After a closer look, it would seem they are producing the spray under their own label.
I went through the process, but didnee buy :-) and what do you know........
They are selling 3 types Priligy, delay wipes and of course a delay spray (Lidocaine 15%) otherwise known as Promescent, which can also be bought off Amazon in 2 sizes 0.07Fl Oz and 0.25 Fl Oz.
don't know bothwell.not willing to give them my email address to access it.maybe others might do so.interesting find though.
Is this company providing the same service? https://www.numan.com/premature-ejaculation?gclid=EAIaIQobChMI5czmvsKw6QIVxLHtCh0YBg8OEAAYASADEgILGfD_BwE
bit like heroin or cocaine then? good idea imo. seriously though i imagine this is in a sense the thinking behind exploring a change to OTC.whilst i am doubtful as to a successful outcome in that regard we may be surprised and it could perhaps be very beneficial.fingers crossed