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My bad- that's the p value for global impression of severity, not bother. Latter given as a % recording a 1 point or greater improvement over baseline, and while twice as frequently recorded in the treatment group, still impossible to interpret in absence of objective treatment effect (moreover, may have involved only single treatment period encounter, and only 38 subjects on treatment. Even if there had been clear objective treatment difference, ITT population too small to support validation).
Bothwell, this certainly has the hallmarks of classic Gibson waffle, simply re-hashing past half-truths, and with lines lifted verbatim from past releases. Or has someone been helping you play with ChatGPT?
As for the PRO results "speaking for themselves", the published data screams "no significant difference in post-treatment IELT between treatment and placebo", a 50% placebo response versus 70% treatment response for subjective endpoints, and probably most damning of all with respect to PRO validation, no difference in global impression of change between treatment and placebo groups at end of treatment. True, the difference between means for Item 3 did reach significance (P = 0.0031), but impossible to interpret this in the absence of clear-cut objective and subjective treatment effects.
So, do you have the guts to look at the data (simple comparison of means is all that's needed), or too frightened to test faith with fact? Or why not cut through the waffle and ask outright "has the FDA accepted that the Phase II study data validates bother as an acceptable co-primary endpoint, and that the PEBEQ is now validated as an appropriate instrument"?
Yes bothwell that is the issue , we need massive growth for some long term investors to even get back to even. Then we would need another big growth period to make long term hold worthwhile. Lets hope they can deliver against the odds!
Dilution has killed our investment but also kept us alive. Need to get 20 x the current SP to get back to evens then make some money!!!! Still go six years!!!
If we require extra money then I do hope it is a loan as they now know they will get it back. Dilution would be terrible for us again.
Bothwell, I don’t disagree. They just need to pull their fingers out and get both China and the FDA sorted without further dilution which has, so far, crippled our investment.
I forgot! From another source.
It's taken time but we have a real winner here.
Thank you very much for sharing bothwell!
Most of what you have posted has indeed been posted before from previous responses, some even recently in my posts. Don’t let the narcissist get to you as it only fuels its problem.
Bothwell, if I am not wrong your posts look like they are from an email response from Jamie to an email you sent containing things the resident narcissist has probably posted. As has been shown many times before, this person knows nothing about the product and only posts to discombobulate (thank Keith) and to get under your skin. As previously recommended, it is best just filtered.
Interesting stuff, bothwell. thank you.
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.