Member Info for bald_eagle

"Proposed Placing, Subscription and PrimaryBid Offer of a minimum of 71,428,572 new ordinary shares at a price of 7 pence per share (the "Placing Price") with new and existing shareholders to raise gross proceeds of a minimum of £5 million"
[18th October 2018]

I thought the last RI was 8p per share, but it was actually 7p. How the mind plays tricks.

Presumably FUM will be having talks with the FDA about the design of this 'least burdensome' trial. Once they know the design they can work out a projected cost...and then determine whether they needs additional funds & how much, from there they can work out how they are to get the extra money. So I'm guessing there should be an update circa September results...until then the threat of a rights issue could hang over FUM SP.
Trial news could obviously be sooner than September.

BackInBlak, just reading the RNS again in case I missed something obvious. The new FDA trial is required for 'clinical efficacy' NOT 'safety' as you suggested.

"The FDA have indicated a requirement for certain additional clinical efficacy data beyond the Company's three months' home use study conducted in 2019 in 1,000 patients suffering from mild, moderate and severe ED ("FM57"). " [yesterday's RNS]

"Your previous post under this thread is incorrect. FDA require a 6 month trial to ensure safety. There is no case for trialing against a placebo again."
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BackInBlak, sorry if I got it wrong. I didn't know the nature of the trial the FDA were asking for. If it purely for safety then presumably it won't a run against a placebo, as you suggest.

"Confirmatory Studies are much smaller than P3, and cheaper"
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How much cheaper?..does that mean they will be able to undertake the FDA trial using existing funds or with only a very small fundraising?

A fundraising (& possible rights issue) was likely in h1 2021 anyway....the requirement for another trial must have moved the possibility of that forward (IMO). Unless Mr Barder can pull a wonderful deal out of his hat (with large upfront payment).

"....EU approval could happen sooner than US if there's no need for such study on this side of the Ocean"
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Frank, I agree with you. If the EU requires no additional data & testing then approval for European markets will happen before USA. That's fairly obvious. But there is the 'possibility' that additional data is required. I'm just pointing out the risk is there. Sorry if it upsets the other day trading ladies.

In the past getting EU regulatory approval has taken longer than anyone expected...especially FUM management (who had on very rose tinted glasses in that respect). But 'hopefully' they have learned from past submissions and can avoid any obvious mistakes & unnecessary delays.

So does the news from the FDA meeting highlight a potential fundamental problem with the FM57 P3 trial....(as mentioned by Bucolic yesterday) that MED3000 (former placebo) wasn't tested against a placebo...it was the placebo!!

It would seem that the FDA may have identified this as a potential problem that required the additonal trial to actually test MED3000 against a real placebo. Perhaps they weren't convinced by Ken James's desktop study comparing MED3000 to academic papers ("...using some of the comparisons with data in the literature...")...an attempt to alay fears that MED3000 wasn't placebo tested.

So why wouldn't the EU regulator behave in exactly the same way as the FDA?..wouldn't they require MED3000 to be tested against a placebo? After all, claims are being made, and those claims have to be clinically proven. It seems we will have to wait until near the end of the year to get the EMA 'Yes' or 'No' answer. Suddenly the FDA approach looks far more sensible...cut to the chase, identify problems early and get them fixed quickly.

Indeed, yesterdays bad news from the FDA meeting may also be viewed negatively by potential pharma partners. Perhaps they will hold fire on signing a multi-million pound (upfront payment) deal until FUM's claims are verified in this new FDA trial. Makes sense to me. Obviously if this is the case then this makes a significant rights issue more likely and sooner than even I expect.

Hey...I'm back. Nice to meet myself.

ScorpionWinger, that's the way I read it too. Nothing aimed at gdog personally...just that the tools he has are clumsy and could be misused (unintentionally perhaps)....which is sort of what gdog has said in previous posts.

Boy Americans can be touchy...they come over here and interfere with our wonderful relationship with China & Huawie 5g, and they get upset!!
PS Just joking gdog.

I guess the obvious question is: Will the EU regulator ultimately ask for the same or similar trial as the FDA?

Perhaps the EU regulatory regimen is substantially different to the FDA route. But there is the possibility that the EU regulator asks for the same or similar data as the FDA. I suppose in the 'long run' it wouldn't matter because MED3000 has to undergo a further trial but it would also mean a substantial delay to EU approval...which would throw a serious spanner in the works for people who are banking on EU approval by early 2021 (at the latest).

The Eagle has spoken!

Rather childish comments by Amanda don't change the fact that todays news re. a further trial for MED3000 is a 'disappointment' (even if it coule be expected). Question is what will happen in the next few days & weeks?

I suppose Kev with his monumental patience will simply see this as a diversion from his very long term view (glacial). Short to medium term the SP could be suppressed by an impending rights issue or other fundraising. Perhaps the sooner they settle it the better...although until the FDA tell them what they want, the scale of the trial is unknown (or can only be guessed at).

Investors don't like unknowns...

Kev, thanks for your concern. I don't believe I have a lack of patience but I don't believe having 'patience' is necessarily a guarantee of successful investing....certainly the day trading ladies on here just won't understand your long...very long post (I almost lost patience before I got to the end and gave up!!). Seemed to have one repetitive theme...you are 'happy' to sit on your hands in the 'hope' that FUM wins through. It's a plan & I wish you luck.
There could be a good buying opportunity to top up at 10p or less....tuck them away in your SIPP and forget about it perhaps!!

So FUM have to rely on a fantasy deal - something Trinity Delta also failed to highlight - to pay for the additional trial. Some people obviously don't live in the real world.

Potential partners can read the news too...they will factor in the information in the RNS & use it to negotiate a better deal for themselves. Perhaps they are queueing up to hand over £ millions to a cash strapped company that is struggling to get it's main product (MED3000) approved by the FDA...seems unlikely to me (but I don't live on fantasy island)

Bucolic, to be fair to theItalian he (or she) is fairly balanced about the risks & opportunities offered by FUM...certainly far more 'balanced' than some posters on here. It doesn't mean that he/she doesn't want to talk up the positive news and slightly downplay the negative stuff....but nothing that most investors (including myself) do. It's hard to be negative about a share you are invested in - in fact it is 'probably' a bad investment approach - because you would 'obviously' divest but could also miss a good investment opportunity. The trick is to find the right balance...to be aware of the risks and to hopefully take action to mitigate those risks. TheItalian was aware the FDA meeting was imminent and the risk that further tests would be required...and 'presumably' that fundraising would may be required to pay for it. Seems to be happy with the risk/reward balance. Others on here just want to listen to fantasy stories.

Bucolic, it's hard to iamgine that FUM would make up the OTC claim but it's really a promise of green pastures once we have climbed the mountain of regulatory approval to get there. A carrot dangled in front of the donkey to keep us trudging forwards.

The meeting minutes presumably should just confirm FUM's understanding of how the meeting went...unless FUM misunderstood - by mistake or on purpose - how things went. The FDA process seems an 'unusualy' process....almost like the FDA is collaborating with FUM to get the product to market. The Americans do things differently!

I imagine the FDA wanted some proof that MED3000 displays the claimed efficay against a 'real' placebo....Ken James desktop study of acedemic studies obviously didn't cut the mustard. I could 'probably' have told him so....but it was worth trying to blag them I suppose.

" I'm very curious as to why someone would waste their time here if not trading or investing."
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Frank, why would serious day traders & investors waste their time here??!!...it's an echo chamber. Whenever anyone puts forward an alternative view - in an attempt to uncover the truth - they are shouted down...accused of ulterior motives or being someone else. You - and the other day traders - need to look at yourselves as much as I do.

Is it really a problem that I write fairly often & in-depth? SHould that really upset serious investors?..or do the people here just want to listen to the echo chamber and fantasy talk of £10 per share. Good luck to them if they do.

I expect the management are in talks with insitutiuonal investors as we 'speak'....I can hear the conversation...."NOT AGAIN!!???!!"

Next question...when will we get the rights issue?

Having the prospect of a large rights issue (or alternative form of fundraising) is likely to hand heavy on the SP. So do FUM's management bite the bullet and raise the money sooner rather than later?

Perhaps Mr Barder will pull a rabbit out of his hat and annouce an amazing deal with a large upfront payment (enough to fund further trials)...but don't hold your breath.

Frank, that was a missed opportunity...to see me gone. I don't like to be called a liar. When I got no apology they were entitled to the full on Bald_Eagle experiential treatment...I have endeavoured to keep up my end of the bargain. Sorry if that has upset you. Sometimes the truth hurts!!!

"Think fund raise will be at circa 10p."
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Gheko, I suspect you are close to the mark. The actual figure will depend upon the amount (in £) and insitutional support. Wasn't the last rights issue set at 8p per share? (I may be wrong here).