Sapan Ghai, CCO at Sovereign Metals, discusses their superior graphite test results. Watch the video here.
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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!
Personally i'm surprised that it is still legal to sell bananas.! only a matter if time i expect.lol
Could you imagine how many people would be arrested today just for thinking that. A few years ago maybe, but certainly not today :-O
Hey darling, wanna see my new 64k banana.....lol
Morning bignose.well that is an interesting take on things.i certainly hope your interpretation is correct.fingers crossed as always.do you think Apple would have had the same degree of success is they had been called "Banana"? hey guys, come and see my new Banana, doesn't seem to have quite the right ring to it.lol
That should have been ‘unrecognised’. Typing on my iPad has always been a pain. The screen constantly refreshes due all the damned adverts. :-( sometimes I’ve even lost whole messages before being able to post. I give up in the end. I’d probably get more posted typing on a banana rather than my apple…..lol