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The results of the PRO validation study that we previously announced speak for themselves. In this US study, PSD502, marketed as Fortacin™ produced substantial changes in intravaginal latency time (“IELT”) and reduced the level of distress experienced by patients, as reflected in the PEBEQ. These results are entirely consistent with the previous extensive Phase III RCTs that were successfully completed prior to approval by the European Medicines Agency. The changes were clinically and statistically significant both from baseline and from placebo, resulting in an eight-to-nine-fold increase from pre-treatment IELT values. Also consistent with previous RCTs, compliance with therapy and with study requirements was high (over 92% completed in this study), and side effects were minimal. Clinically and statistically significant differences between Fortacin and placebo were observed in the FDA-favoured domain (“Item 3”) of the PEBEQ (p< 0.0008). At the request of the FDA, Item 3 was designed to determine the degree of “bother” that the patients were experiencing due to the condition. For PRO validation, excellent correlations were also observed between changes in Item 3 of the PEBEQ and the domains of sexual satisfaction, control and distress captured using the Index of Premature Ejaculation (“IPE”), one of two PROs used in previous studies. The terms such as “bother” are important because they are used in the final approved prescribing information (“PI”). Overall, the study confirmed the safety and efficacy of Fortacin. This PRO validation study was unique to the US FDA – it was mandated by the FDA and our results were submitted to the FDA. The NMPA in China did not require a validated PRO so Fosun was able to push ahead with the Phase III study.
Genetic manufacture Fortacin on a separate commercial production line. Currently, Genetic has total free capacity of 5 million canisters/year. Genetic is already planning to expand its production capacity by up to 20 million canisters/year starting in 2027, by building/adding a new production line for pMDI/pressurized canisters. So again comments in this paragraph aren’t correct i.e. “no contract pMDI manufacturer in Europe will increase capacity” as clearly Genetic is expanding production.”
For China, yes, the reference product is Senstend, which is the marketing name for Fortacin - it’s the exact same product, just a different name for China. Therefore, it follows that the CMC documentation is exactly the same whether its Senstend or Fortacin so its completely wrong to say no CMC data exists. Genetic has the CMC data, including stability data for China which is 30 °C/65% RH at various time points starting at release, 3 months, 6 months, etc... And no MHRA authorisation has not expired – regulatory consultant filed in February 2024 with MHRA for the first 5-yearly renewal application for Senstend to MHRA. This should result in the GB MA being renewed for a period of unlimited validity (no further application would be required in a further 5 years).
Bothwell, do us all, a favour and just give it your email address since you need to hold dialogue with it. That way we won’t keep getting the green filtered lines which conflict with all the red boxes.
Dearie me, Bothwell, you really don't get it...or has your friend been whispering?
Genetic was approved on the back of a Type II variation for Fortacin manufacture, with revised specs and accelerated stability data. The bioequivalence and Phase III studies used clinical trial supply from PSNW, different in several respects to the current commercially supplied version. Reference product is Senstend for which no CMC data exists (and for which MHRA authorisation may have expired). NMPA may not accept the Fortacin variation/dossier equivalence without supporting data and may require RT stability (zone 1-IVa inclusive).
On supply, Genetic operate two pMDI lines for three generic products. Fortacin requirement is so low that I believe it's being manufactured on a separate small volume line used for product work up and clinical trial supply, not the commercial lines. The HFA phasedown means that no contract pMDI manufacture in Europe will increase capacity until low-GWP propellants are approved and available (China also accepts the Kigali amendment, albeit with different timetabling).
As to claims around study data, the "strongly positive" Phase II failed to demonstrate any significant post-treatment difference between Fortacin and placebo (the latter giving a mean six-fold increase in IELT over baseline, p=0005, versus an eight-fold increase for Fortacin). No difference in perception of post-treatment benefit between drug and placebo (p=0.3585!). Study data is in the public domain, and explains why no progress has been made in the nearly 30 months since first FDA review. Now, China Phase III did involve a longer treatment period, so perhaps less chance of drug/placebo overlap, although a year on, only RPG have referenced the study, whereas Fosun was very quick to publish the bioequivalence data (publication of Phase III data would not impact on NMPA review). I wonder what Fosun makes of the US data?
Six years to make up the shortfall, Bothwell...tick....tock.
Is my friend correct or incorrect?
Bothwell, you appear to have perked up since your whiney "I've lost all my money" posts. Tell me, has your "friend" manifested himself again or are you back on the lithium?
And simply no the assumptions aren’t correct.
For example, the CMC data is not missing - if it was how could Genetic be approved by both MHRA and EMA as an alternative manufacturer? Also, the US phase II results and the phase III results in China as previously announced were successful in meeting their primary and co primary end points. Further, supply is not an issue…
Sorry just in response to our friend.
What do you mean bothwell? The money fountain was mentioned many years ago and has never been repeated
What was the name of the disgruntled employee?
I dont’t. Been assured there is a Money Fountain on its way!
I hope I am wrong but constantly left confused about what they tell us in announcements and then what actually happens afterwards ( or what doesn’t happen )
Do keep up, Bothwell. Dr "Bigger than Viagra" not involved since end 2022, currently playing around with some ancient injectable ED treatment (3 parts sand, 1 part cement?).
Dougie's six years a tad overoptimistic- US died forever five minutes after first Phase II data analysis, China submission likely permanently hamstrung through missing CMC data (and perhaps dodgy results), along with macro issues (supply, Fosun restructuring, market potential and the looming HFA phasedown). Hope you have a pension Plan B in place.
Wow Dougie! 6 years and you don’t think we will get China nor USA!
Has Dr Mike left the ship???
I think we will be lucky to get an update announcement on fda trials before then bothwell! With a bit of luck China might take a step forward at least by then!
Will we see a re-rate in the SP that they spoke about, get the product to market in China and USA before I require my pension in 6 years……
Bothwell, I cannot agree more. The whole company is run by incompetence. People who think they know a lot but actually no nothing at all and I mean everyone. It’s been nothing more than a disaster with nothing but lies and misleading information.
Regent Pacific Group Ltd on Tuesday said it has agreed to acquire the shares it doesn't already own in Plethora Solutions Holdings PLC, valuing the premature ejaculation treatment company at 11.65 pence per share.
The deal values Plethora at about GBP95.9 million, based on the number of shares in issue, and at GBP114.3 million when considering its fully diluted share capital. Shareholders in Plethora will receive 15.7076 new Regent Pacific shares for each Plethora share they own. Shares in Plethora jumped by 18% to 5.30p on Tuesday afternoon.
On the 10th March 2016 Regent Pacific Group Limited (“Regent Pacific” or “the Group”; stock code: 00575) is pleased to announce today that it has successfully completed the acquisition of London AIM listed Plethora Solutions Holdings Plc
Well 8 years since this day, so much has gone wrong and the SP has been decimated. Jamie wage packet has pocketed him millions since then for not producing any results…. A product that is required by so many men but we can’t get it to market in China or the USA.
Sad to see my investment dwindle to an all time low and no sign of it recovering soon due to dilution.
The money fountain hasn’t begun to flow…..
Written off my six figure investment.
so april has passed with no china news.why would regent state on the 28th march that china submission expected by end of q1 (haven't checked the precise wording as can't be bothered,but you get the drift) if i said i was expecting something to happen in a couple of days or so's time i would be basing this on fairly reliable information,not just hope and guesswork! perhaps that explains why i'm not on the regent board.now utterly ****ed off with this farce!
Morning Bignose, thank you for getting in contact with the BoD and asking the correct questions. It really is a shambles that China isn’t further on and the US is not closer to completion. Can believe JM is just paying Jamie to do nothing. Dr Mike seems to have vanished off the scene. Dilution was a terrible for us private holders but good for the BoD. 2025 has now move to 2026. I finally have no confidence in the BOD had my investment has gone.
Well another new low today with a market cap of 9.33mil squid. Not bad for a company that has a needed product which has been on sale in Europe since Nov 2016......COUGH.
Certainly agree re the Chinese effort which seems to have stalled. Over 6 months delay with no real reason given as to why they keep missing dates, but then again, it is nothing new with RPG.
Well at least some activity at DLI
https://twitter.com/Deep_Longevity/status/1781211957413986356?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet
nothing very significant of course,but at least some sign of life.
massively disappointing that no confirmation yet of chinese NDA submission.what is the problem with these people. so unprofessional!