Member Info for Odysseus07

ED is not in the minds/ Hawknose is so wrong. Some of it is (small minority and then anxiety if you have ED that happens once or twice). But usually (80%) of the time it is due to a physical reason. Often it is an eraly warning sign that the patient has high blood pressure, arterial narrowing. As the pen ile arteries are so small/narrows that it happens here and then later heart/cardiovascular problems. Also a sign often of early stage diabetes (pre-diabetes). IN the mind is a very old fashioned and discredited view medically - that was the belief in the 1980s

It was late after a long night - fair point. Bad choice of words, but i think most people would get context

hi all. To be clear, FUM say that MED3000 is a vehicle. it is. THERE IS NO ACTIVE INGREDIENT. That faield last december as was no different to med3000 (with no active ingredient - just the solvent). READ FUM THEMSELVES. GOOD GRIEF> WHAT DO YOU ALL INVEST ON?

Now. The vehicle could still be beneficial and "work". Like for dry eyes. Just that it raises doubts for ED - a really serious condition, unlike dry, tired eyes. But the phase 3 showed that MED3000 had a significant response. But there will be questions.

But it is a vehicle, no active ingedient. THat is fact! Read FUM !!! They have been honest

Ananda and all - the markets have risen so much over last two weeks. If we are so close to "great news" and "50-£1". Why is FUM going in the direct opposite reverse to the WHOLE market. Please answer.

DONT CALL ME odious< liar ETC. JUST ANSWER. And dont say because its "AIM". As AIM is rising with the bigger markets. PLEASE ANSWER!

Fill your boots. catch that falling sharp knife :)

Why would that annoy people? I bought £1000 worth in 2000 or so at £0.80. Anybody else held these shares for nearly 20 years??? ;) (And thats how long FUM have been saying "next year, we will be in the promised land") :)

Tend to agree eat my. So about Feb time (just before March FDA trial starts) there will be a fund raise. I will prob buy in then at around 10p, I am estimating - take advantage of the offer in a high risk bet. With money i can afford to lose.

Hi all. I think people asked about this. I wrote a long answer this morning and then either this site or my internet crashed. Anyhow, will write again.

Why will ema approval (if it happens) be at least Q3 2021? Because in 95-99% of cases, the EMA do not approve on first submission. I work in this field. They have some questions or clarifications. These can be minor, medium, severe or ask for a new trial or ask for new phase 3 trial. In order of severity. So you see, the FDA asking for a new trial is not "minor". So there will be at least some questions. EMA have not yet responded to the approval submission by FUM. So will be Jan now at earliest. Then FUM need to see the response, clarify and then respond. Taking us to at least April. Then the EMA need to assess the response and then either approve or ask for more clarifications or say the answers were not good enough. This takes us to July/August. Then this "positive recommendation for approval" needs to be rubber stamped - procedural, taking us to Sept/Oct. This is for relatively minor clarifications. I agree, if very minor, will be sooner (but not before July - Q3 2021).

Now, i think the EMA, like the FDA ,will have fairly major questions. Maybe not a new trial, but maybe. And they could want to wait to see the outcome of the FDA trial. This is due to start in March 2021, going to Sept/October 2021, so FDA approval not until Q1/Q2 2022. And same timing for EMA if they wait to see the results (they risk looking stupid if they approve and the FDA trial fails).

In addition, at least medium questions are likely as for the last 10 years it was the active ingredient prescription medicine that was being investigated (Med2005). This "failed" in December 2019 (no difference to med3000 - the vehicle or "placebo"). This is a very unusual result, no real mechanism of action why has been explained.... and EMA will think it strange that after 10 years, a sudden change to in effect just the "unstable solvent that works by evaporation and the cooling sensation sparking nerves in the pen1s to get an erection - like deicer on hands or sanitiser alcohol gel). The EMA will look at this and have at least medium questions (as I say they always have questions even when Phase 3 results have been totally as expected/hoped for).

Lastly, brexit. Will have no delay. Anything submitted before brexit is binding on all signatories. Hope that comes across as objective analysis and is helpful

Your friendly Odysseus :)

This is what they say below. Sounds positive (assuming regulatory approval and trial success, like any small pharma). My question is this though, it says it thinks no partnership deal until regulatory status known (that is normal and makes sense). But this wont be known until FUM needs more cash (runs out Q2, so need cash by Feb latest). So how will they raise the money? Share offering and price dilution?

We expect the partnering discussions to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share."

its down by about 15% since the peak of the RNS. How is that rising?

i know! i would have made 30% profit or so! Still, no worries. I am a convert to ananda... who wants to sell for £1.09??? Im in this to £9.01! :)

lol. I bought on 2002/2003. 47p was nowhere near peak. Try 87p. I think even they have even been over a £1 (briefly)

test

Hi all. What do people think are the reasons that the share price has not moved (maybe 0.5p either way) from a low point, after the recent RNS? Leading from that. Why did the SP jump from 13.5p to 16.5p immediately after the RNS but now is back at 14p?

Different trial centres question from BE. In theory nothing. They all follow the same protocols (inclusion criteria, endpoints). In practice there may be different standards. But usually not - normally centres are chosen that are good (for obvious reasons - pharma companies, including FUM dont want to waste money on centres that dont have good standard operating procedures). So dont think this is a factor - the 50 pts in MED3000 arm and 50 in cialis arm will in effect just be two groups for analysis, irrelevant of the ttrial site

thanks NDR. That is a part of my job, but didnt want to get technical. Yes, the odds ratio (margin of error) will be a lot higher so harder to show difference with cialis (not a a bad thing) but also harder to show an effect... and outliers (in a random patient selection, we could be unlucky) could cause an effect...... small numbers are not safer.... thats why most trials fail at phase 1 / phase 2.....

Honest question. Most people are feeling that Med3000 and FUM are on track, and RNS mostly positive. Why is the share price not much higher? Why down today? I dont want a rampers vs negative debate. What are the reasons ? Is it that the market thinks "well, fine, no real news either way, all depends on the investment partner and the confirmatory trial?". Is that the reason? (by the way the trial is a risk as low numbers mean small differences can becomes "significantly" different and then all people will hear is that low-dose cialis is "significantly" better than Med3000. And that will kill commercial deal and the product. If no significant difference then agree, very positive for med 3000

BE. im going off the fact that FUM said in their RNS earlier in Sept I think taht there was £2million cash left and this will run through to start of Q2 2021. So about £2million every 6 months? I dont have their wage/office bill though etc

Well. To play evils advocate. The investor may see the Phase 3 results and think "100 patients - should follow that trend". It should. But smaller number of patienst means higher risk of individual outliers affecting the result (in terms of greater affect or smaller affect). Also, the investor can write off some of that against tax and will have insurance if things go wrong. And the potential prize is a lot more than £3million. Of course, as people know, there are also risks. Wait!!! what am i doing???? i want the SP to go to 13p, so why am i ramping??? Answer: Maybe i am just analysing. Maybe too much and as backinblack said, maybe miss the boat.

The figure quoted by Liberium (and repeated by Ananda) of £2-3million sounds about right to me.

So, to me, if £2million lasts for about 6 months (taking FUM RNS info) then the amount of funding needed is £3million for FDA trial. Plus 12 months say running costs from Q2 2021 = £7million. Thats known. If the ema also want a similar trial (unlikely to just accept FDA one, but they could ay they dont need one) then another £3million.

So rough capital funding of £7-10million needed until Q2 2022.

There is about £2million left in cash for running costs. So enough (according to FUM) until Q2 2021. So money will be needed for the FDA trial and also 9-12 months running costs until approval and revenue (unless of course teh initial commercial deal broadens, which with good news and results would be likely)