Today's RNS If the data is clean and highly compelling then yes they will submit for approval and I bet you if this is the case they will also sign a deal in which case they will have the answers to those questions. the day A lot of work related to packaging and product manufacturing and stability tests have already been done.
Today's RNS I’m not sure we’ll get a study completion RNS. Phase 2 RNSs went from recruitment closes to results. We shall see.
Today's RNS It looks a bit out of date: Recruitment Status : Recruiting Last Update Posted : June 25, 2019 But yes hopefully by the end of the month we get a RNS on study completion, then the market will start looking forward in anticipation of results. FX & Aberdeen, we know if P3 is good FUM will apply directly for EMA approval, do you know if in that process they check the supply chain &manufacturing of the product like the FDA does? surely for that to happen they need to have signed a deal with a partner?
Today's RNS Staying on the subject of study completion date. This link clinicaltrials.gov Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the... Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction - Tabular View. gives Oct 7 as the estimated date. If you’re interested, clink on the study details tab and then scroll down to find the full 80 page study protocol.
rommy1 I see you're posting on advfn, another site with an active FUM discussion group is lse.co.uk again with free registration and a higher level of debate
Thoughts on Future Market Cap Fx - it is my understanding that the open label has already begun. 300 patients will be in the open label for 6 months and 100 will continue for a further 6 months. The feedback from one of the presentations was that they were very happy with the safety profile (as per the data from the PK Study which also backed this up)
Thoughts on Future Market Cap Wow Mr T. The world is indeed a small place! Thanks for posting that. To add a little to the risk profile thoughts: Does anyone know if the open label safety assessment has already begun? Because if it has, before the 3a study has been unblinded, would IMHO infer there were very few adverse side effects in any of the 3a subjects (placebo or actual dose). Otherwise, it would be very foolish to subject the Open Label participants to the highest dosage. GLA & have a good weekend
Thoughts on Future Market Cap Good post fx24. That sums up why I am here. Gla from St Louis Missouri.
tommy1 your post will not be seen unless you first register with ii.co.uk(free research account)as that is where this FUM dicussion is taking place.As stated we need all the USA exposure we can get.
Thoughts on Future Market Cap I agree everything primarily depends on the quality of the data. Additionally, it will depend on the length of remaining patent plus whether or not there’s any easy route to increase it eg Glaxo tweaked the molecule used in Acyclovir to get to Valacyclovir in order to get a fresh patent. The other factors are quality of the differentiation compared with the existing therapies (which I think is very strong) and finally how keen a large player would be to have what I think (if the 3a data is good enough) will become the market-leading therapy. And let’s not forget a potential re-birth of CSD500 which again, I think is a great potential product that the right player could challenge Durex’s lead with. I think your valuation range may be quite conservative (with great data). With this in mind, what would one assume (at this stage where the 3a study remains blinded) the potential probability for achieving great data is? 50% 60% 70% 80% ? I would suggest our current market cap implies a very slim chance of achieving great data which I personally do not believe is the case ie the current Risk:Reward is huge.
Thoughts on Future Market Cap FX, I did some calculations a while back and there’s a wide margin when it comes to valuations. I estimated a share price between £1.80 and £3.60 implying a market cap of around 360 million pounds to 720 million. However calculations are just calculations. They don’t mean for much. The most important thing is to show increased efficacy as the dose was increased in these trials. Not long to go now (less than 3 months)
Good post fx. That is why I am here. Greetings from StLouis Missouri!
Thoughts on Future Market Cap Our market cap is sitting at around £65m. I understand that there’s a high element of risk in the sense that so much rides on the quality of the MED 3a results. However, IMHO the risk:reward is ridiculously high. Why is this? My former working life was centred around the Pharma/Biotech sphere. My ‘new life’ is centred around the Tech startup sphere. In this sphere, initial potential demands securing adequate early stage funding in order to launch what’s known as a minimal viable product. In the UK, this funding market has been getting a lot better than it was just 5 years ago. However, the risk tolerance still remains far lower here than in the USA. So much so that if you can raise say £500,000 in London, you’d likely be able to raise $2 to $3m in Silicon valley. I think a severe lack of risk tolerance in the UK is why our market cap is crazily low. FUM is after all a start-up. Indeed, this is in a sense backed up by the fact, that despite some good UK PR, at present, we only have one institutional investor (LO). The likes of Neil Woodford’s (formerly risk tolerant) fund being hammered, really hasn’t helped matters. However, the situation has the potential to reverse quite rapidly IMHO. Firstly, if James Barder & Co present FUM well at the large US sexual health conference in October, this could result in very favourable US PR. If American investors were to see what I would term “a shockingly attractive risk:reward ratio†in this small startup British stock, you could see a rapid rise as a consequence. This, as in the America, you just wouldn’t see risk:rewards anywhere as attractive as they are here. America has a very established long term investment structure for both risky and less-risky proposals. As a consequence, most innovation takes place on their shores. Secondly, if the 3a data is good or excellent, that ‘high risk’ is immediately markedly lowered, thus opening up to a much larger plethora of investors (both private & institutional). This is before you take any large Pharma interest into consideration! The above is why, like Daring Aberdeen, I’m in to the (hopefully sweet) end. GLA
Today's RNS There’s been high FUM volume for a while, but I don’t understand what the IIs are doing. FWIW - I was thinking we might see LOAM trim their holding some more if we do get a rise up to news.
Today's RNS Someone/some people have left considerable ‘buy’ orders out this morning. Does anyone know of any positive share tips on FUM across the weekend’s papers, magazines? Or are LO buying again?!