The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Looking over the FDA submission
1) Highly positive FM71 Phase 3 Study Results with all primary and secondary endpoints achieved
2)FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeksSecondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication
3) The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000
4) Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement
5) The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID").
6) FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement
7) Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favourable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion whilst using the product versus 4.3% of MED3000 users;
Why would any of the big boys interfere,when Lilly or Pfizer could simply step in and buy this company out. Remember they never had an OTC topical ED product. This would be a low cost take over and provide them with the perfect addition to their market share. In fact this could become an interesting battle . No international ED company is going to ignore the massive upside potential this product offers. Once they clear the last hurdle ( FDA) then expect the fireworks to follow.
Both stx and agl were all about COVID-19 . Now their revenues have fallen off a cliff. When Futuna gets going with an OTC worldwide ED product I dont see any comparison . In fact this will become a potential takeover target
The Ed market is huge both in RX and OTC. And if this gets approval from the FDA I will be amazed if this company is not bought out. The big ED players could buy this for next to nothing and reap the hard work done Futura. That said all the shareholders would no doubt profit from the sale, but it would be a lost opportunity when it comes to the run on the share price over the coming years
This has to be the most frustrating share I have ever bought. Talk about fundamentals; no matter how much positive news there is out there the SP fails to follow. Have all IAG planes got Lead wings only nothing is taking off !!!!!!!!
The fundamentals of the company going forward are strong. They have a constant trickle of PR's which again will help restore confidence. By the end of the year this should surpass the 30p mark
once the knee jerk reaction has past this should fly
19.7 p opening price
Anyone get an opening price on this?
Thu, 31st Oct 2019 07:09
RNS Number : 7587R
International Cons Airlines Group
31 October 2019
NINE MONTHS RESULTS ANNOUNCEMENT
International Consolidated Airlines Group (IAG) today (October 31, 2019) presented Group consolidated results for the nine months to September 30, 2019.
IAG period highlights on results:
SP at OCT 31st 2019 = 482p
·; Third quarter operating profit €1,425 million before exceptional items (2018 pro forma1: €1,530 million, 2018 statutory: €1,460 million)
·; The quarter was heavily impacted by industrial action by BALPA pilots, which together with other disruption resulted in an adverse operating profit impact of €155 million
Earnings per share up from 0.3p to a wopping 2.7p
Well you cannot say that the report is not positive after all this wait!!!
https://investors.dxdelivery.com/download/companies/dxgroup/Annual%20Reports/DX_38041_Annual_Report_2021_web.pdf