Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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Reading "the response", I can't help but wonder whether Jamie has been replaced by ChatGPT, and set to "random irrelevancy" mode .
Perhaps a cunning ploy so that RPG can blame the AI when the they finally 'fess up to the US being dead? And the complete waffle around supply cerainly indicates that JamieBot 1.0 needs a better training set.
But if anyone has a mind to interrogate JamieBot , why not ask about the status of the reference product, feedback on the NMPA position on use of a historical clinical supply product and incomplete CMC data. Oh, and where's the "excellent" Phase III data, given that Fosun was quick enough to publish the bioequivalence studies?
So, it started off...... A case of the invisible "f" :-)
So, it started of and held for the majority of the day at +11.11%, come the late afternoon and close, that was changed to a loss of -4.44. Certainly some antics going on.....lol
The.Italian,
As I mentioned before, one needs to copy all 3 and the company secretary, however. I notice that the last secretary who was announced a couple of years back (Winnie Liu) is not listed in the shareholders communication document but is attainable through : " in writing to the attention of the Chief Executive Officer or the Company Secretary of the Company at" info@regentpac.com.
I assume they are now using this since it would appear Winnie has also left as her email address no longer exists, so the system has informed me. They are then obliged to answer otherwise they are not following their own governance.
https://www.regentpac.com/ICMServlet/download/174-2517-4663/ShareholdersCommunicationPolicy%20(English)%20(final)%20(20240327).pdf
Bignose - thank you very much for chasing them up and getting that reply then sharing.
As usual now it’s a case of wait and see - the twists and turns of life can hopefully do us a favour !
Morning bignose.no i hadn't seen it,so thanks very much for that. interesting that mellon through galloway is prepared to extend a further loan.small beer to him of course,but presumably indicates he can still see some light t the end of the tunnel.i agree it's prudent to be sceptical about any rerate in view of the history here, but i suppose it is possible. q1 is now over and no news on submission,but as you say could be any time.
kudos to you again for pursuing a direct approach to the board and eliciting the response posted yesterday. tbh, i had completely given up on a direct approach in light of the wall of silence which seemed to prevail.very glad you have proved me wrong.
there were 2 or 3 nuggets of information in their reply,which i will comment on later, hopefully.
Morning The.Italian,
In case you may have missed it. In the annual financial report Galloway have again made a loan to RPG for 2mill usd, hence their going concern can continue another 3 months. This is exactly what happened and was needed to close out the phase 2 trials. Hopefully they won’t want to pay this back with additional dilution.
They are of the opinion that there will be a significant rerate following the Chinese submission announcement, although I’m not going to hold my breath since the sp dropped following the license agreement announcement. Time will tell regarding this once the submission is made which could be any day/week/month or year now….lol
Bignose,thanks very much for the detailed post.much appreciated. need to look at it in detail later.
Continued
As for Europe, Recordati has not communicated any price erosion since Fortacin was launched OTC. And once you go OTC you lose market exclusivity – market exclusivity only applies to Rx status. And having just checked with Genetic, the manufacturer that has replaced Pharmaserve, at “this moment it has total free capacity of 5 million canisters/year. Genetic is already planning to expand its production capacity to 20 million canisters per year with a start in 2027, by building/adding a new production line for pMDI/pressurized canisters. This estimation by Genetic already includes regulatory approval by AIFA (the Italian regulatory authority). And as for the monthly production, Genetic confirmed that it can produce circa 416k canisters per month (but not all months are equal due to August and Christmas being red calendar periods).
And as for impurities, since Genetic has manufactured Fortacin it has not had one manufacturing issue so impurities is of no concern.
Lastly for shareholder value we are working on addressing this and we believe that value will accrue as we hit certain milestones (like any drug development company) – and one of the key milestones is Wanbang filing the NDA in China. This is a key step in getting Senstend approved by the NMPA and Wanbang then commercialising it. This should significantly provide a re-rating for the company, subject to market conditions (as you know the markets in China and HK are in a depressed state).
Enjoy :-)
With ref to the below response.
Although positive regarding the can production, the timing of NMPA milestone payment and income from Recordtai may alleviate the need for further dilution. Although given there are no II's, is it the companies intent to have further dilution once the SP has been rerated (as mentioned at the end) so they can easily issue II's with shares without an explosion in SP due to the lack of free shares available. Could this be the reason for the 20 to 1 consolidation in available shares such that when the dirty deed is done there are not billions and billions ? Just my speculation, but could be logical as JG surely want sa few II's once an income stream is seen.
Also I have requested some breakdon on how Genetic (this is the first time I am aware that the can manufactureres name has been made available) will produce 416k/month given they have stated athat each batch is only 30k.
Also, going by what he mentions about money for the FDA phase 3, it certainly would imply there is no licensee willing to take on the responsibility, or even if there is a licensee interested !!!
Below is the response:---------
As you know we have released our audited results for the year ended 31 December 2023 and in that announcement the Directors adopted a going concern basis, which included a cashflow forecast for the 15 months ending 31 March 2025. As further stated, the Directors are of the opinion that the Group has sufficient working capital for its present requirements, that is for the 15 months ending 31 March 2025.
In respect of the US, we have closed out the Phase 2 study in the US and submitted the study results to the US FDA and commenced discussions with the FDA on the SPA and the Phase 3 Study protocol. We are continuing our discussions into 2024 and we formalised the clinical study protocol. The US FDA has said in its most recent correspondence that it has reached agreement on the major elements of the clinical study protocol, including the overall design and study endpoints and more importantly the FDA specifically stated that it had no clinical hold issues and that we could proceed with the phase 3 study. We are now currently redoing the study budgets by seeking quotations from clinical regulatory organisations (to project manage / operate the study) together with estimated timelines. We are also reaching out to royalty financing funds / companies that provide drug development / clinical study financing on a potential non-dilutive, non-recourse basis to advance Fortacin through the phase 3 study. If and when an agreement is reached an appropriate announcement will be made to the market.......... continued.
Bothwell,
I cannot help feel that the FDA process will take much longer than 2025. Firstly, according to the 2019 presentation, the FDA wants 172 subjects and given how long it has taken just to sort out 87 for phase 2, it could take 3 years before the NDA is submitted. Then there is the issue with manufacturer, which has not even been discussed and of course the pre launch marketing and distribution logistics. (Would they really only want to launch in one state ?).
With China it could be another 2 years before any income stream is seen since they have stated they intend to target 9mill subjects. That is going to require a production line which can produce at lease 300k cans/month and that's if they only intend to target 3.6mill sufferers.
Anyway, I did email the company and had a response a day later (As i wrote it pays to copy the big 3 -Jim/Jamie/Mike plus company secretary since they are then obliged to answer. as long as its not abusive which in my case needed a lot of restraint....lol).
Anyway, I'll post the response which does make for some interesting reading regarding finance requirements, although I have asked for further clarifications. It certainly reads as positive for Europe although I am still skeptical since we have heard it all before regarding timelines and what their future plans are.
I would love to retain your optimism bothwell but mine is long gone! It’s damage limitation at this point and I’m just hoping we can pull something back respectable . How can faith in this team still be here with what has gone on so far ?
I love the optimism even though it is, yet again, a significant distance way. At 90% underwater on this particular ‘money fountain’ I will be truly delighted if your optimistic prophecy materialises.
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.
And of course a new low.
And today it dropped by over 18% and in fact the buy was at 0.4 so 21.57% drop on only 30k shares !!! One would think whoever sold would want 0.51. So, as mentioned before MM funny business.
Dougie, you've got to be joking, haven't you ?
They would expose themselves to much ridicule:
Not able to follow any of their timelines.
Not keeping shareholders sufficiently updated.
Have next to no transparency.
Continually providing misleading information.
Making bad investment decisions.
And
Totally demolishing shareholder investment.
Has anyone ever asked anyone at the company about the prospect of doing an interactive meeting where we could actually query what is going on? Never see or hear from the management apart from the announcements once or twice a year. For hefty salaries you would think it would be a legitimate request from shareholders
Morning The.Italian.
Not just less than 1000, but half. It will probably drop by the same % today.
Afternoon bignose.agree with that.i haven't bothered to calculate the value of a 10k trade but it is less than £1000 think.these anomalous rises and falls on derisory volume don't mean anything imo.still t least it was a rise.
It has happened before on a one lot buy or sell. Who knows the machinations of the MM's, although I don't think the lack of shares available is a reason given the MM's must be holding quite a few themselves now. Of course nothing like the liquidity last weeks annual results would have us believe.
Here a 10k, there a 10k, everywhere a 10k. Old Jim Mellon had a farm...E-I-E-I-O...lol
Why the 17% jump today.
Another tweet.presumably this is,or is part of,the new launch referred to in the results.nothing exciting,but just for info. https://twitter.com/Deep_Longevity/status/1775968994643562996?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet
As I've commented before on the absence of any observable activity from dli for a considerable time,i should perhaps point out a tweet now,which is the first i think for 8/9 months. nothing of significance in itself, but at least a small sign of life
https://twitter.com/Deep_Longevity/status/1775596244968092123?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet