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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
Morning The.Italian,
With respect to the “significant and previously recognised demand”. The only thing I would write about that is. If Recordati didn’t see that, why would they spend so much time patently waiting for PSNW to solve the issue. Then get their own recommended manufacturer to sort it, unless they are really stupid, which, going by the companies progress year on year, would indicate otherwise.
Obviously only time will tell, but they certainly do give the impression that they still have (in the words of Charles Dickens) great expectations. ;-)
No problemo.
Sorry about all the typos, although luckily for me you got the gist of it........ lol
Morning bignose. yes difficult to understand how impurities was allowed to remain an issue for so long. anyway, issue now is can they actually sell enough cans to provide some form of tangible income. 30k to 416 k seems an unrealistic step up unless there is some very significant and previously unrecognised demand,which does,i'm afraid,seem very unlikely..
The.Italian,
One could understand that now given the manufacturer is effectively linked to Recordati, being they sourced them and are now in some way linked to them them, but before, however. I certainly agree when it comes to PSNW who were contracted by RPG and who were the ones who developed the first cans. That said RPG had some responsibility to drive the solution with the impurities which they obviously didn't since it took them nigh on 5 years before Genetic stepped in and solved the issue within a year. But this the problem when the company has none with the necessary pharma experience or should I even write business experience.
Anyway, it will be interesting to know how sales are progressing in Europe and how many cans they manage to offload. So far its not looking good at 30k cans every 6 months which certainly doesn't reflect 416k/month, let alone 416k/6 months.
@The Italian:
“Clinical hold”? Only occurs when there is something scary in the AE profile, such as unexpected safety signals or an increase in known AE prevalence- a complete non-issue for a simple knob spray containing generic APIs. Bizarre that JamieBot even mentioned it.
An IND has no formal time limit. It can be voluntarily inactivated by the sponsor if no clinical development for two years (but may be reactivated with a new study plan). The FDA can terminate if the IND is inactive for five years. Of no relevance here.
The “To SPA or not SPA” question is moot since the Phase II failed to show a significant difference between treatment and placebo in the Phase II study in key objective and subjective endpoints. No validation of “bother” as a co-primary endpoint means no basis for continued SPA discussion.
Proceeding in the absence of an SPA without a very high degree of confidence in a novel endpoint relevant to the label claim would require a very large two-part study (600+ subjects plus partners), with everything hinging on the mercy of an AdCom. The only unknown here is how long does RPG believe that it can keep up the pretence about US submission.
We’ve supported several royalty financings (working for both biotech and private equity). Put simply, it’s a secured loan where a lump sum is provided in return for a share of existing or future royalties and milestones payments (“synthetic royalty”). Popular with small biopharmas who need to get a late-stage asset over the line, and for companies with a marketed product who need non-dilutive pipeline development support.
Benefits are that the developer retains commercial rights and IP ownership, and no fixed payment to service. Agreement structure is obviously deal-specific, but generally involves payment of around 10% of net royalties, although some are in the 18 to 50% range. Most deals are capped. Over half are signed after NDA acceptance. Royalty agreements may be resold.
From a diligence perspective, RPG would not get past the first phone call, principally because they do not own the “asset” (robust, long-life IP is the singularly most important requirement), followed by zero experience in product development (and let’s not forget the going concern issue). the nature of the asset (no established regulatory path, non-reimbursed lifestyle product), no clear route to de novo market creation and revenue generation, and no barriers to competition. I could list a dozen further reasons, but you get the drift. Just like the whiff of desperation emanating from RPG…
Sounds like JamieBot 1.0 needs a complete rebuild…
Genetic were the named manufacturer for Senstend (the reference product for China). The EMA approval was withdrawn mid-2022, leaving only the MHRA authorisation (effective December 2021 after the Brexit reset), and which I believe may now have expired due to the sunset clause. Senstend has never been manufactured, meaning there is no CMC dossier for the reference product. Submission depends on the NMPA being willing to accept Fortacin CMC data as a surrogate. This in itself may not be complete (for example RT stability). Genetic must agree to be the manufacturer for the submission (NMPA inspection is required), but they do not need to sign up to product supply.
The bioequivalence and Phase III study were conducted with Oompa Loompa manufactured material with a different specification and enclosure. Batch specific CMC data is needed for the NMPA submission, and again this might not be complete (or forthcoming).
As an aside, no contract pDMI manufacturer will extend production capability due to the impact of REACH regulations and clarity around non-HFA substitution.
Thanks for the further info bignose.does seem a tad odd to be saying basically we have no say in the manufacturing process etc. one might have expected some degree of mutuality in the rights and obligations under the licence agreement which would give regent some say over things.i suppose when you are in such a weak position as regent is, having enforceable rights on paper may simply be an academic point in practice (no alternative).sorry im just chuntering i know.
Oh , And I forgot to add.....
Given there is no time limit between phase 2 and 3 could mean that this could go on for months just trying to sort out financing which then obviously impacts when the final approval could be given and when the product could be launched. Like most LTH's, I just hope I am still alive to see it.....lol
I guess its a bit like he tried to give the impression he knew a lot about the cannabis market......lol
NOT.
And he writes as if he has vast experience....."as with any drug". What the fcuk does he actually know ???
The.Italian
Actually I just asked JG about this and how much they would probably take. Also, I questioned; since according to his last response that if and when an agreement was signed, is there a time limit between phase 2 and phase 3. Apparently not, but that's as much as he was willing to write. Also, I surmised that since they were possibly going go down that route, that surely indicated no licensee (and there meant to be a few) was willing to sign an agreement and take the small risk in subbing the phase 3 trials. Again, no answer on that which could mean there is a licensee around, but then why mention the royalty route in the first place? So, I would guess JM/JG probably feel a better agreement could be signed once approval is given (like FUM and Eroxon), although it surely is a risk given no one is that keen now ?
The response regarding the number of cans available, I feel, is very lacking in RPG feeling any responsibility to ensure the best value for shareholders. But it is in keeping with they lack lustre attitude to date. The last sentence says it all (We cannot be bothered - Plethora is not involved in this process as we just collect royalties and milestone payments) . Notice he tried to shift the blame from PRG to Plethora. So its all their fault PLE and Dr Mike are not more hands on !!!
"As with any drug, manufacturing is always the pressure point vis a vis supply, which isn’t necessarily a bad thing and if Genetic produce 5 to 20 million cans per annum that’s a good thing for all stakeholders. And please remember it is up to our licensees to sort out manufacturing and ensure they have sufficient supply to meet their demand. Plethora is not involved in this process as we just collect royalties and milestone payments.
Anyway, it is what it is and hopefully news will be out soon re the Chinese NDA submission, although, once announced, I do expect an SP spike with the usual slow decline over the next 18months, until a can is readily available for joe public to buy. (Again a bit like FUM and Eroxon)
Morning bignose. yes i imagine royalty finance is like that.you take a percentage of ultimate royalties etc,which could impact future earnings dramatically. all speculation of course and i suppose the other side of the coin is that mellon has considerable resources at his disposal,so not in the same desperate situation which some companies are in when they resort to damaging finance options. anyway time will tell.on the clinical holds point,i agree that a potential finance provider would certainly want the reassurance of a formal SPA before proceeding.i probably didn't express myself clearly,as i was just wondering if the no holds statement indicated any real progress with the fda and was not suggesting regent might go ahead without one. lets hope for NDA submission news without further delay.
Morning The.Italian,
I would suspect royalty financing is a bit like all those lawyers that offer a service whereby if no win, no fee. seems rather similar to me. Remember the US is full of these sort of used car salesmen types who will do anything for money, probably even perform clinical trials if they think they are onto something. Maybe they left a calling card under JG's or JM's car wiper..... lol. It does sound all rather sleazy though :-)
Regarding the no clinical holds statement, Again I would suspect that the no win, no fee needs some security. ie. They want to be sure there are not going to be any outstanding clinical issues, otherwise its far too risky to take on, which seems obvious enough. Maybe I am misunderstanding your point ?
And note Galloways loan has an interest rate of 8%, so JM will make sure he will never lose out. Its a bit like JG's loan just after the Yooya fiasco. He was given the option to have either taken shares or had the money repaid, both with an accrued 4.75% interest. You will notice he didn't take the shares since it was based on 0.225HK$ and the price had dropped significantly. Instead, he took the money and interest out of the rights issue which then went towards paying for his rights shares. So JG is sitting in a rather nice place.
I think we may start to see more share action and possibly volatility due to the impending Chinese NDA submission which is due any day now. Maybe even an announcement this evening (I'm only speculating on that since we are already a week behind)
So a couple of other points which I have been made aware of in a second response.
Although the Chinese NDA submission has been delayed by 6 months, effectively due to the additional documentation for Manufacturer. It would seem my speculation on them seeking approval for a Chinese manufacturer is completely wrong. In fact the extra time is so they can change to Genetic . An extra 6+ months seems a little extravagant given it surely is just a case of changing out certain documentation. However, maybe the time is needed to translate, review and edit. Of course one would then think. Why the fcuk didn't they do this earlier when the new manufacturer had been found to be able to produce consistent quality cans ???
Well, we all know what the above means. The effective 416k cans produced each month will be split between Recordati, Orient and Wanbang. The point I am making is that although they are supposedly targeting 9mill in China, they already know they would be targeting a lot less. Yet just another totally misleading statement given to shareholders.
The other point which I wanted clarity on was how they were to produce 416k/month given a batch has been stated to be 30k cans. If you remember, I was provided with a breakdown on hours a 50k batch would take PSNW to produce which it turns out was 39.5 days and included: cleaning, filling, quarantining, testing, packing and shipping. The response I received was that Genetic can produce 5mill cans/year = approx 416k cans/month. That's fine but it would mean that 30k can batches are continuous being produces with no mention of upscaling on batch size ? Does it really matter then, how big a batch size is then. I think not....so why all the fuss on batch size ??? Just my musings on this as I like things to add up.