The.Italian/Kieth, I also get the impression that if an agreement is signed with a strategic partner/s for the US market it will also unlock the possibility of agreements for the Middle East and Latin American regions since they seem to value the FDA approval process, which could occur anytime between now and this time next year. Just my opinion from the recent updates.
Keith, I think it will be sooner than that. It may take 3 to 4 years to achieve significant sales in the US, but then it depends what each of us considers as our end game? The SP will have risen significantly (IMHO) long before then, based on a license agreement being signed and final FDA approval about the end of next year. Of course if one is to include China in ones end game, then I agree 3 to 4 years, but who will be waiting for China before selling a few at a significant profit ?
This will all come to fruition as long as there are no further ****ups and incompetent delays. AIMO.... ;-)
Ill believe this when I see it....... but still positive in the right direction
Recordati, PSNW and the Group are looking into options at scaling up the manufacturing process to meet the anticipated demand in OTC with the aim of manufacturing approximately 50,000 units per batch order and reducing the risk of supply chain shortage and unreliability.
Still no mention of if the manufacturing problems have been solved.
Dougie, certainly right there. And as usual the Sun's article, like all their articles, is rubbish. They mention the UK, yet wales, Scotland and Northern Ireland have no sufferers....Seems they don't know the difference between the UK and England. I wonder if they actually know what Brexit is.......LOL
My understanding is (horses mouth n all that) that RPG are going to take the risk and start phase III before the phase II readouts, however. The start date all depends if they have recruited all the phase II participants and sorted papereork as stated in the announcement. So any time after the 1st August. (Think that was the date given as recruiting timeline). I'm sure the update will include all this be it good or bad news.
Hopefully the operational update will include something along the lines of "all phase II subjects have been recruited, we are now progressing with phase III. And because the EU has approved for a switch to OTC, the FDA only requires 1 subject which will now be completed within a week"...... LOL .... I wish...... ;-)
I would think the last few trading days volumes were indicative of some internal knowledge with some prepared to take the risk, which isn't to say the rest of the market know about it or want the risk. It will be interesting to see what reaction there is to an announcement., however. Given the lackluster volumes on the China and Taiwan announcements and the knowledge that EU sales were a disaster combined with the company continually reneging on dates may make investors understandably cautious to the risk particularly at this moment in time. Hopefully I am wrong, but historic incompetence could be an influence.
I was thinking more along the lines of how stringent the FDA phase III requirements would need to be. I wondered if there was any possibility of a relaxation on the FDA part. Just toying with the idea.
Of course it may also influence a licensee coming forward sooner and signing that invaluable piece of paper given its now OTC approved. Many scenario possibilities. We will just have to see how it plays out, but it must surely have a +ve affect.
I wonder if the recent FDA delay is linked to this very OTC approval. Is it just a pure coincidence that when phase II is meant to finish and Phase II starts, Recordati receives the EU OTC approval ? Dr Mike, although involved with the FDA approval process, is also helping and advising Recordati on the EU.
Obviously a revenue stream is needed, even if just to show II's that the company is worth investing in, however. Given that the new sales push will not happen till Jan 2021 and it would take at least a year to see any influx of money (remember we only get 15% of sales), they really do need to get the China money and a US license in place (with added upfront payment) for the company to continue given its yearly ...what is it, 4mill USD expenses ?
Its currently all touch n go if another placing is needed for the short term since they have no money and Jim will only lend so much. That said, as long as you hold, any income may be used to buy back the placing shares at a later date (just my thoughts). I am actually hoping for a good rise before JG's shares his the shop floor so I can sell some and buy back in after the loan dilution. It would be even better if, and I am only dreaming here, a US licensee buys the license for the states at a huge amount (or a lesser amount if they own a substantial number of shares...who knows if it isn't a licensee who has secretly been buying?) before JG's shares hit so we can all sell out at a huge gain, otherwise. If it happens after his shares are included, we all suffer with some dilution........ pure fantasy on my part as I am sure he will stitch us up for his own begotten gains.... ;-)