Member Info for Odysseus07

i assumed FDA trial starting in March (that is a decent assumption). And the EMA process outlined as I did, is not the best outcome. Best outcome is that EMA have no/minor comments on submission dossier and approval in EMA in Q1 2021. But that, I think, is extremely unlikely. As we know, there are lots of questions on the Phase III trial (and probably in the unseen clinical study report). So best case scenario is Sept/Oct 2021. Best realistic case for FDA is Q1 2022. Is the market priced in for that? I think the recent upswing (last couple of days, as opposed to the 50% decrease from May to start of October) is due to people buying stock thinking approval is 3 months away.... and also on rumours on FUM being bought by pharma.... That could happen, but again, given their very chequered history, i dont think big pharma would at this stage (the fact their flagship active drug in effect is not better than a cheap solvent wont help with being bought). So, when this lack of apporval happens in next 3 months, with funding, the sP will decline. And that, if no major major problems highlighted by EMA, is when i will buy again.

Other people seem to keep mentioning the PhD. I mentioned it once. And it's a DPhil. But lets move on.

I would say that there is a 10% chance of the EMA approving MED3000 just on the first submission dossier. There could be major or minor additional info needed. It could be as major as another trial being needed (that is actually quite a major requirement). I get why FUM play it down by saying "small trial of 6 months" but it still basically means the FDA question the (as we all agree - surprising and not wholely positive Phase III results last December). EMA get back to FUM, lets assume Jan/Feb. Then assuming no new trial needed by EMA< FUM still need to look at comments and resubmit - taking us to June. Then EMA re-evaluate, take us to October 2021 (FDA 6 month trial probably runs from March to Sept). So October 2021. So if all goes relatively well, the n Q4 2021 EMA approval, Q1 2022 US approval. But given the history of FUM / MED3000, the "odd" results of the Phase 3 trial, i dont think the above is the most likely scenario. I think "best" outcome is approval in EMA and FDA sometime in 2022 and i dont think the market has factored that in to the price. Thats my thinking, hence why I will buy after the new funding announced and the SP dilution. Or buy some more, to be accurate.

What are yours - and others - scenarios / thinking? Rather than people just saying "$5billion drug". Good grief

I made a mistake on the submission. I agree. If only more people admitted to their mistakes. The rest of the points are true. If no pharma partner by end of year, then FUM will need to raise capital. Why would a pharma partner buy now when FDA need another trial to confirm results? The FDA will likley ask for chnages in trial design to make sure there is no other effect in place rather than the vague "solvent evaporation" MoA. Also, EMA will have questions after 10 years or so of research on an active ingredient that now is being stopped for a drug delivery system (MED300). But in ED (a serious disease) this drig delivery system does not deliver any drug, insyead by a solvent evaporating it increases erection. Erm, ok.... it may get approved but there will be lots of questions. This delay will mean pharma wont take over/fund and FUm will need more capital, which will decrease share price. A lot of people here seem just to be hoping that this AIm healthcare stock just "gets approved" and shoots high upwards. But dont actually understand the mechanics or what the actual product (now) is.

No its not. Read the RNS. They said the EMA would get back to them by Sept. They havent. So the EMA would have said why/maybe given new timing. FUM should update. Do we all agree FUM said the third meeting / final agreement on what is needed by the FDA trial is due "october". Again, if no news on this or a pharma partner by November, there will be market disappointment

yes bald eagle. Read the RNS. FUM said they expect to hear back from the EMA in September. Its quite important, no? I mean they could approve it? So fairly important. But i assume the EMA have not fed back yet (usually with lots of questions/what is needed to gain approval or any concerns on a first submission). FUM should really update as if the EMA had told FUM "SEptember" then they will have also told FUM "Sorry, we are delayed" due to COVID or whatever. That's all im saying - no update.

Im just seeing that a lot of people here seem to think that MED300 was the treatment and was planned (after 10/15 years research). Its not. Its the vehicle - the delivery system for the drug (like with the CBD pain treatment). It's a bot like saying that the CBD treatment didnt work, but the delivery system eased the pain by evaporation. Ok, fine..... i suppose. But the regulatory bodies (FDA and EMA) will ask a lot of questions with a company changing tack after so long preparing the active ingredient.

? that's higher than the 22.30p you quoted. Bizarre

Morning Bucolic. I think you are referring to the highest SP at close of each day. Intra-day, the SP went higher. I remember it once hitting past 25p. And wasnt checking it each day.

Cheers

I could. The thing is, as i have said. I have a portfolio and this would be a bit of fun gamble. But yes, I could you are right. Maybe put in half now and half after announcement on capital raising. Hadnt thought about splitting this "fun" amount.... I may do that tomorrow, i have the idea this SP will drift back down to 12p as there will be no news this week

oh good grief. Do one. In july/august, SP was as high as 27p. So the RNS obviouskly didnt go down well. Stop being so blind/biased. Jesus.

no, it was "high 12" but wasnt that really. It was this feeling that SP will decline in Nov when they need more capital. And i dont see a partner being announced before end of November. Otherwise i would have bought. I realise that if a partner is announced, the SP will jump to 20p. Thats the gamble i guess

Since the last RNS, the SP has declined by 50%. Obviously the market is disappointed with progress. Approval/progress is delayed relative to market expectations. So a rise of 3.5% is just normal day to day fluctuation. The trend since the RNS is decline. The next trend? Who knows. Depends on the news - no news yet of EMA comment on the regulatory submission (my bad, I was mistaken on that. Apologies). But FUM said they expected to hear by end of Sept from EMA. So I think that is delayed. And no news yet on FDA third meeting / trial design requirements. FUM said they expected to update market by end of October. So 2/3 weeks for that. SP could jump based on that outcome. Or decline if bad or if no news. Also, by end of Nov they will need some new capital..... so that will drop share price (unless they secure a pharma partner). But again, no update/news on that. So all that lack of progress / update is why the trend has been decline and a 50% decrease in share price. The future depends on the above (obviously)

My mistake, the product dossier has been submitted. I didnt see any updates from the EMA review in September? So, approval if all okay, is end of 2021 and probably longer in USA, as that new 6 month trial, the design has not been approved yet, let alone started. So this delay in approval, or market expected delay/more funding needed, i assume is the reason for the 50% decline from mid-20s share price?

unless i am mistaken.

No, im not saying that. Im saying that FUM have not submitted the EMA dossier. If they had, they would have announced that (it's a big step). They havent.

Once filed, takes about 3-6 months for EMA review and usually ask further questions. So about 9 months from submission to approval. FUM indicated to the market that they will submit Summer 2020 (i.e. June). Failed to do so. No update. So earliest submission now is Jan/Feb 2021, then 9 months earliest approval - end of 2021. Market priced in approval Q1 2021 - SP increased because FINALLY some positive light at end of tunnel. Now, at best, end of 2021 - and so market disappointment and SP decline.

Those are the facts Italian. So, yes, agree, 2021 was the approval.... but early 2021 (as FUM implied to the market) and end of 2021 are two very different things - and massively affect the share price

Hi Italian. This is the actual words below from earlier in the year (Feb 2020 I believe). The reason why the SP is suffering so badly is that FUM have given no update on its filing. It hasnt filed to EMA with its submission dossier. And given no update. Result is that the market thinks "no news is bad news and further delay". So, submission now, by my guess will be earliest Q1 2021, then with EMA review and questions, approval will be Q4 2021 at the earliest. Possibly EMA will wait to see the FDA trial results and that will delay things further. But all in all the market is disappointed and SP sees significant decline.

Your reading of the vague FUM updates is quite positively biased. Mine may be slightly negatively biased but on thw whole, i believe, more objective than yours.

“We are encouraged by our initial interactions with the regulators which endorse our early advice and belief that MED3000 will be approved as a medical device with strong clinically proven claims and remain confident that we will be in a position to file in mid-2020 in the EU.”

Thanks Eat. As I say, if/wehn i do buy between 8-12p, this will be my "high risk/potentially high return gamble" and a bit of fun. If I lose the money, the rest of my portfolio with dividends will cover it. If MED3000 passes the second FDA trial/gets EMA approval then FUM will go to about a £1 (and 0.60p very very quickly) . (BUCOLIC - AM I NOW A RAMPER????? IF SO LETS SEE THE SP RISE TOMORROW!!!!!! ;)).

Good luck to you eat (and all) and your portfolios. Interesting times. And importantly, stay healthy, your loved ones stay healthy, and keep your jobs/income. I myself almost lost my day job, so good luck all :)

To answer the two points:

1. If i am a deramper and my deramps bring down the share price by 50% over a few weeks, then you should really question the actual inherent value of the share and company if I can have that much power. Come on. It's because the market sees no concrete delivery/results just constant "promise".

2. This is the reason i think the required funding will bring down the share price. From the last RNS, FUM will run out of money by "Q2 2021" so lets be generous and say June 2021. The FDA we know want a second 6 month trial. If you were a potential "big pharma" partner why would you invest now? Why would you agree a deal now? If i were them, i would look at the facts - 15 years of developing their active product, then a Phase III trial (after many false dawns) that shows that all this research gives a product that is no more effective that the solution vehicle the active drug was dissolved in (I.e. MED3000). Then after the possibility that this could be a "medical device" and over the counter route rather than prescription only (ok, fair enough, but normally this route of medical device is not normally one for serious conditions like erectile dysfunction).... the approval date has been pushed back (originally it was April 2020 and then "Summer" 2020 and now with the FDA trial it will be H2 2021).

If i were a competitor, i would say "lets save our money, FUM valuation will go down and it may fail the FDA trial as in effect they are saying the solution evaporating causes an erection - and this after 15 years' research?? OK... lets see if it passes the FDA trial and if they cant afford it, they go bust and our competition problem solved. If it passes the trial, then we buy at low risk to ourselves. Either way, we dont fund a trial that could fail....after all the past doesnt inspire confidence.

If big pharma think like that, then FUM will need to raise capital buy - either by taking on more debt or selling more shares. Either way, this will decrease the share price. This capital announcement will have to be made by November as (as i say above, they run out of money in June 2021). So I think - why gamble now, no news until end of November and by then the SP dilution will have taken affect and also will be news regarding EMA approval (gone very quiet since the Summer). That's my thinking. Not deramping. Investor rationale. And so far, my predictions have been proved right.

I think my next move will be to buy these shares (as a gamble) when the dilution funding is announced. I am not a deramprer, just an objective investor. I hope no investment "newbies" took the advice of Ananda or Bucolic..... the shares now are heading towards 10-12p for good reasons. These shares are very high risk and should only be a "gamble" element of a portfolio. I think these are almost at lowest point and be a good gamble buy come November (after funding dilution is announced).