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If the market responds well to just a confirmatory RNS about a response, imagine what the market response to approval news could be….. lol
Results which could contain a small update re FDA and China due any minute now.
Morning The.Italian.
I see a small FUM RNS has been uploaded to say a response to FDA has been made and they are on track to receive approval in Q2. Luckily, I bought a few more a few days ago.
That’s 6 to 7 weeks before and after the rise so 12 to 14 weeks….lol
Is there really such a thing as a long pump ‘n’ dump ?
A rise to over 4A$ and back to 2.75A$ in a 6 to 7 week turnaround ?
And luckily for me, the buy was processed after the 7%+ drop..... ;-)
Only time will tell on that, however. It’s more likely they receive FDA approval than not.
I have also just bought a few shares in FUM, given the expected news re FDA. I really don't see there is any contest since the ointment contains next to nuffin....lol. The FDA approval alone should have some +ve impact.
Morning The.Italian,
Thanks for that. I must admit, it doesn't surprise me given, as I mentioned before, there must be millions of similar cheaper apps around. Only hardcore fitness/health freaks would probably consider it and then pay for it. Also, they obviously didn't have that much faith in it since apple only accounts for 28% of the market whereas Android accounts for the rest and felt that given the numbers, even Androids 73% wouldn't add up to much. It will be interesting to see if the B2B side creates an income. Although ERP quoted the Longevity market as being worth 83 bill USD, I'm even less confident now given the app obviously generated next to no income from such a huge market with absolutely no thought to the Android sector.
I'm pretty sure you are correct about the mobile phone apps. Can you imagine the number of similar apps which charge next to nothing for monthly use that there are out there ? certainly a huge number and many of those have been around for sometime in one form or another. Hopefully there is money to be made by 3rd party companies that purchase licenses and the more fruitful maintenance contracts. Only time will tell of course, but I wont be holding my breath for any large income amounts. They may just make enough to pay for JG's salary, if that. Probably best to sell the whole thing on once its sorted together with the DLI employees.
Morning The.Italian,
It would be interesting to know what the commercial deal is. Are DLI paid each time it is used or is there some short-term (renewable) multiple user license agreement? I could be wrong, but, given there must be many apps which are touting for the same business, I cannot imagine there is at present much income.
The.Italian, certainly cannot argue with any of that. ;-)
Morning The.Italian,
Did you spot the deliberate mistake ? I wrote JG’s salary as pounds, but it should have been in USD., even so. Still excessive. :-)
Given it’s PLE who are sorting everything out, it does beg the huge question. What the fcuk does he do ???
That should have been “15 mins ago”. ;-)
To put into perspective….posted 15th s ago on the BBC News website.
Former Shell CEO Mr van Beurden's salary was £1.4m in 2022 and the company made a whacking 39bill squid for the same period (he moved on in Jan).
It certainly makes our CEOs salary package laughable (for JG that is). No profit since 2013 and a salary of 1.5mill squid. (Although that was reduced to 1 mill during the pandemic which I’m sure has gone back up).
Something to think about…..lol
Also interesting that PLE are the ones to file the dossier in China since I would have thought Wanbang would need to do it, unless its because it is outside China ? I wonder why China have not taken this opportunity to find their own manufacture ?
Morning The.Italian,
Interesting, but expected, although it did slip my mind. Any UK related approvals now have to have their own approvals (re the addition of a manufacturer). I would assume all other things approved before Brexit are automatically approved with no change.
Morning The.Italian,
Although the FDA process is ticking along, there still seems to be a lot of incompetence given their previous announcements.
According to the June 6th/22 Update....
After incorporating the FDA’s suggestions and recommendations into the Phase 3 protocol, the Company’s clinical research organisation has also completed the Phase 3 Study protocol, together with a ‘Type C’ meeting request, with the FDA for the product development of Fortacin. This meeting between the Company and the FDA should occur by mid to late September 2022 (being within 75 days of receipt by the FDA of the meeting request). We are hopeful that after providing a fulsome reply to the FDA’s advice and request letter and incorporating the FDA’s recommendations and suggestions into the Phase 3 study protocol, that the Company can proceed with its Phase 3 study shortly after the ‘Type C’ meeting.
Yet, they now state that the Type C meeting request wasn't made until Dec. No explanation has been given as to why their request for a meeting was refused, although there was some teleconf!!!
I also notice that they write that a clear NDA submission pathway has been agreed with the FDA, yet that agreement was already in place as announced in the PLE RNS 9983B. "Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application"
As I wrote previously, given how long they have taken with the phase II, I really don't expect FDA approval till late 2025, if not 2026, which is incredible after they stated they would have approval by June 2017 in the first place (June 2018 with the extra 12 months for the 6 dose can debacle) . It certainly calls into question who is making it up...the FDA (I doubt) or our management.
I think everything now relies on China, which, I am sure will progress on schedule. They certainly make ERP's efforts laughable (and it even started 3 years after the US and that's allowing for a years delay because our lot hadn't checked the Chinese authorities had the necessary approval paperwork for the drugs used).
Anyway, it will be interesting to see how things progress with Recordati as there are no more excuses. And of course no more mention of PSNW who I guess have been sent packing with their tails between there legs.
They need to sort a license agreement this year otherwise it'll be further dilution (if Recordati don't sell many cans)
Certainly could have included a lot of the information in the prospectus. And there appears to be no mention of import license approval for Singapore last June.