Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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.
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.
Morning The.Italian.
Not just less than 1000, but half. It will probably drop by the same % today.
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
Whoops, apols for the typo. Even kids would be able to spell “capitals”…….derrr
Morning The.Italian,
Not wanting to pour water on your optimism, I just wanted to point out that regarding the FDA process the company has never been right on timelines and have even deliberately misled shareholders regarding progress. Hence we surely cannot trust anything they write on the companies progress since historically it’s going to be wrong.
As to Dr Mike, apparently his wife works very hard and is very competent. I have not had any contact from him for 3 years now after I criticised Jamie who was unfortunately copied in a reply I made. Jamie responded in capitols as all kids would do……lol
Contd....
Then there was the Yooya fiasco, thankfully for us shareholders that didn't work out, but just reflect if it had. RPG wanted to pay 15mill usd for the company yet today its worth 1mill and last year closed shop in Japan, their supposed largest Asian market!!! RPG even stated in the fall out (remember the delay after delay after delay in getting the paperwork out) they had a more concrete investment, but gave no information and still have not clarified what that was all about (more likely a deflection from the embarrassment that Jim couldn't get his own way and would subsequently lose face).
Although I have written many times on the incompetence shown by the company, the above few examples are much much worse. How can a company publish such nonsense. How can a company still be run by a BOD and CEO who have absolutely no idea what is going on in their own company? It certainly seems Jim is totally oblivious to it as is shown by the rubbish he writes in the chairman's statement. Obviously he is being fed information he is supposed to write (that's if he actually does write anything).
I would have much rather they injected whatever cash they had into completing the FDA process instead of wasting money on the DBC and the DLI which have done nothing but cost shareholders dearly in money and consequently dilution and ultimately share price. I cannot see any income coming from the DLI to help alleviate the constant call for cash to keep the lights on particularly given they don't even announce when deals have been agreed which must mean they add up to next to nothing.
What's next ? who knows, but one thing is for sure if they don't sort their finances out for the next 3 years, come 2025 there may not be a company still around for us to discuss.
Although I am somewhat disappointed with respect to the Chinese submission as it now delays possible approval by 6 more months which will add time to when any income stream is seen. If they have not sorted a manufacturer till now, I would suspect they wont have sorted out distribution of product etc etc either, meaning that any income from the 9mill target sufferers may not happen till the end of 2025 or even the beginning of 2026 and that's when sales will start so RPG may not see any money till towards the end of 2026. If that is indeed the case and there is a good possibility that may happen, what money will the company run on ?
There may be a 4mill usd cash injection (less tax) triggered by the approval, but that surely will be used to offset any loan to get the company even to that point. Surely there will be a point when even Jim will get fed up loaning the company money and seeing no return. And then what about the monies needed for the phase III they cannot run a phase III without spending more money???
The FDA process has been nothing more than a car crash since the beginning. They wrote a lot about how it was there main objective however, its been nothing more than a disaster time after time. The original unambiguous FDA RNS in March 2014 with a follow up to say they expected approval by June/July 2017 was nothing more than lies. There has been no announcement as to why and what had changed changed. Instead all they did was kept giving excuses and delays. The phase II which was for only 100 subjects (I'll write that again 100 subjects !!!) has so far taken nearly 6 years from when shareholders were told recruitment had started, which it didn't. It then started at the end of Dec 2018 and was supposedly going to take 15 months and be completed by March 2020. 8 months into the study, we were told that the study would be completed 3 months early and be completed by the end of Dec 2020. Meaning that over 50% of subjects must have been processed, however. In Jan/Feb 2021 shareholders were informed only 15 subjects had been processed, which meant effectively the statement advising of a reduced timescale was nothing more than a known lie. And what about the licensee. The media were told in 2014 that the company was close to signing heads of terms with a US licensee. Yet still no reason was given as to why they walked away and stayed away.
Mie must be Mike's wife, hence unknown.....lol
Cans if……lol
Bothwell, I suspect the delay on the China submission is because they are now also sorting out a manufacturer. Why they didn’t do this a year ago beats me. Particularly since it’s very clear the new eu manufacturer will not be up to the job. China needs at least 1 mill can is they are targeting 9 mill sufferers in the first year.
I must admit, I didn't see the China delay coming since they were going great guns. Seems they are also looking for a manufacturer approval too which I guess is obvious, although I would have thought they could have made the submission separately. Maybe they were requested to make them together ?
Recordati's manufacturer would be hard pressed if they can only make 30k cans every 4 months and for Wanbang to target 9 mill they are going to need 3 or 4 production lines at least (remember it took about 6 to 7 weeks for PSNW just to produce 50k cans).
After a quick squizz and summerising. Delay, delay and delay and only fumes in the bank. No China submission and the FDA phase II still going strong and still no SPA. Incompetence rules OK.
Yup, early This morning.
So……. What’s happened to the results ? They are usually announced an hour or two after the board meeting.