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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).
Is my friend correct or incorrect?
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 was the name of the disgruntled employee?
I dont’t. Been assured there is a Money Fountain on its way!
Wow Dougie! 6 years and you don’t think we will get China nor USA!
Has Dr Mike left the ship???
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……
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.
Not when you have been here since it was in the pennies.
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.
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.
As I said a year or so ago, I have a feeling that 2025 is the year we will see the approval in the US complete and possibly a China at the beginning of 2025. Jim Mellon isn’t investing his millions in here to keep Jamie living he could just move him to another of his companies.
Why the 17% jump today.
I think if Bignose or Italian asked some of their questions to Jim Mellon he would respond. The journey continues.