Member Info for bignose58

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.

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 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.

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

What I am curious about is. How does she/he/it/they (that's to cover all sorts) know this ?

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

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

FYI

https://www.geneticspa.com/en/

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.