The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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I think if Bignose or Italian asked some of their questions to Jim Mellon he would respond. The journey continues.
Whoops, apols for the typo. Even kids would be able to spell “capitals”…….derrr
Morning bignose.no problem.optimism is probably going it a bit.just relief that we did not get the bad news i was more than half expecting. i do of course,entirely agree with your post (and yours dougie,morning).the level of failure to advise as to promulgated developments is what you would expect from the most tin pot of aim companies and this is,despite its pitiful market cap,a main market company.anyway, question is will we get an announcement of china submission in next couple of weeks or silence and more delay?place your bets.
i hope mrs wylie,who is after all an innocent bystander in this sorry story, does not take offence at my poor attempt at humour,or else i shall also be exiled to the realm of those to whom no communication may be extended!
bothwell good morning to you also. i suspect we are,sadly, very far from mellon's thoughts now.
Maybe time to email Jim Mellon with your thoughts Bignose?
Why do they take offence when people question announcements that turn out to be incorrect? Constant delays , stating negotiations with certain territories are taking place for years but never a sign of a deal , unanswered communications showing no regard for investors.
of course investors will be angry when they feel they are given false hope , how could they expect anything else . Especially when share price has been obliterated through this time eroding any value for people.
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
I am assured that Mie Wylie is a charming lady and a highly competent CSO to boot!
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
Ok the link hasn't worked.im not a member. it says chief scientific officer for regent and plethora from 2016 and gives time as 8yrs i month.
His linked in profile suggests he is still involved.obviously this is not reliable as he could have failed to update it,but 8 years and one month from 2016 would make it current.https://hk.linkedin.com/in/mike-wyllie-0057b411
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 have sent him a couple of emails but no response from him. Usually very good.
Is he not involved at all anymore? I thought he would be the one directing how to get USA across the line? obviously we do not get much clarity of who does what and whats going on so difficult to have any clarity.
Very much doubt it,bothwell. china is being run by wanbang bio, so doubt wylie would have had any influence even if he was still involved with regent. aimo
Is the delay’s in the US & China due to Dr Mike Wylie no longer being involved?
Cont.. as to dli, again i have been very concerned by the apparent lack of activity, so the statements today are mildly reassuring. they may be complete blather of course, but i note the reference to "some public hospitals" plural (although the first reference is to hospital singular). if they have indeed started to gain some traction in the hospital sector this would be welcome news and perhaps a prelude to some takeup by the insurance and actuarial sectors.revenue from dli is so far minimal, but i am encouraged by the reference to new products,so again perhaps all is not lost here.
so that's the positive aspect of my response.on the negative side there has been virtually no income from any source.exponential growth of sales in EU seems unlikely based on past experience,but who knows.this leads to the fundamental problem now, which,as you say bignose, is that we are once again running on fumes. finance is needed urgently. will mellon provide some form of loan (convertible loan notes perhaps) or will they go for an equity raise.if i had to guess ,id go for some form of loan,as i doubt there would be any appetite for an equity raise outside of mellon and co (remember the virtual lack of any non mellon take up for the rights issue) this assumes mellon is prepared to stump up a bit more cash rather than write the whole thing off,which i expect is quite likely if we are on the cusp of getting china on to the next stage etc. expect news on this front in next month or so,imo.
Had a couple of re-reads and i have to say my principal reaction is one of relief. i had been seriously concerned that the months of radio silence were indicative of not just delay,but rather of the occurrence of some fundamental and insurmountable problems,which would put an end to both china and us objectives. so, at least so far as china is concerned, i was relieved to see that things are still on track, albeit with an unwelcome delay on the manufacturer and supply front. if they do indeed complete the agreement in that respect and the submission by the end of this quarter (not a lot of time there) then it will be a positive and very welcome step forward.
the fda position is still very unclear, but at least they are not saying that the process has run its course and is now dead in the water, so some relief there also.
as to the suggestion that a manufacturing and supply agreement is unlikely ever to be completed for china, the words "as the agreement has now been finalised" do appear, even to someone of my limited intellect, to be fairly unambiguous. i accept that regent's history does lead one to be cynical, or at least cautious,as to the accuracy of formal statements,but for the time being i am prepared to go on its face value until proven otherwise.
i note the reference to SPA request in november. whilst not absolutely clear, i take this to mean that a request was made in november and that the resulting questions are now being addressed. the outcome, i accept,remains uncertain, but still a slight hope there. tbc
All as predicted months ago...
Absence of supply agreement is just part of the CMC headache- expect continued submission delay, and if it ever gets that far, NMPA pushback on material differences between clinical trial supply and commercial product among other issues.
And still the pretence that there's the prospect of progress in the US, or for additional licensing deals...this pathological level of dishonesty/self-delusion suggests that RPG is bettered suited to pushing crypto investments.
Morning all. glad they have arrived.had a cursory read as a bit tied up today. will mull things over and re- read later on.
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.