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If I had written what FUM3 have written years ago about the P2 trial I would have been hung drawn & quartered. That the P2 trial was garbage & totally untrsutworthy. 3 years ago it showed That FUM had a wonder product (MED2005)
"pinky and perky"
I'm too embaressed to admit it but I think I still have a 'pinky & perky' album somewhere in the house.
It must be worth a million at least...or is that my FUM shares. Perhaps I need to relocate to fantasy island....the bungalow next door to that 'happy' couple Amanda & 'the Joker'...perhaps we can go skinny dipping together!!......although Amanda is one ugly woman.
I have to agree with theItalian, Oddyseus is a bit of a disappointment. With his (or possibly her) advanced education I would have expected a more academic analysis of the comments FUM made on the P2 trial. Instead they concentrated on their 10-12p target.
Almost like I have been led up the garden path...was it a PhD or someone with a GCSE!! PLease extrapolate or interpolate...or just be honest!!
and lo and behold right on cue, another well reasoned and cogent post from the short thing.its a bit like the pinky and perky of the deramping world, so for those of you too young to remember the originals, here is a reminder. https://www.youtube.com/watch?v=Xsr_k1wKSWI
well odysseus the facade has well and truly cracked hasn't it. no semblance of credibility left whatsoever. just another agenda driven, hectoring, would be manipulator and not even a very good one.well at least you are giving everyone a good laugh.
Buyer exhaustion soon. Propped up only by RNS feeds, a good opportunity to short. When September comes and another fundraising is announced then watch it plummet. Ody your 12p prediction is only weeks away. A good time to make money on yet another shorting opportunity.
so, to the people who said it would be in the 20s. Can we now agree this was balderdash. Based on nothing. The shar price barely changed week on week. I ask again, why would it? Short of some people buying on a hope quite a lot of stock. Why would it? When there is no news until September? And that news is likely to be a delay to timings. So the share price will sink back to 10-12p. Then i will buy some and take a gamble, if all else is looking positive.
I suggest you get some relaxation time in and watch some test cricket BE. A game of strategy and patience much like investing.
A six month trial will give more data sets that can then be analysed statistically on their merits. The notion BE that you have proved by looking at the two existing trials carried out that everyone using MED3000 will take 4 weeks before noticing any improvement in their ED condition is misleading. The greater the number of subjects and the longer the time frame will give a more accurate correlation of the wider population of ED sufferers. A smaller study will naturally contain more standard error but does not mean that every ED sufferer in P2 trial failed to get any benefit. The P2 trial was clearyl not as robust. It is often the case that P3 trials will give more meaningful results for that very reason. But your opiion that everyone in the P3 trial must have waited 4 weeks to notice an effect is not based on any factual data from the P3 trial.
"The sample size may well be smaller in FDA confirmatory trial but the time scale is considerably longer, six months."
NDR, so you have gone from the P2 trial being too small (insufficient patents) to being insufficient duration. Mr consistency you aint. You really have bought into the FUM spiel hook line & sinker.
The duration 'argument' just doesn't make sense (IMO). If MED3000 is going to work & show results straight out of the box, it will work on day one of any trial. Not often medical devices take a month to reach full effect....most people would have lost interest well before the 4 weeks were up and stopped using it.
The FUM 'answers' were illogical and smacked slightly of desperation...."Think of anything quick"
- "Insufficcient marketing budget"....no, not relevant and used before (many times)
- "The company dog ate an important P2 dataset that would have corroborated the results"....no, even too absurd for FUM
- "The P2 trial was of insufficient duration"...perfect
- "The P2 trial contained flaws (TBC)"....perfect, but needs fleshing out
The sample size may well be smaller in FDA confirmatory trial but the time scale is considerably longer, six months. But you don’t have a scooby about the numbers that will be involved, the type of trial that will be used, the statistical methods that will be employed. For someone who prides himself on a mechanism generated by facts you are just putting out your speculative views and conclusions based on no facts at all. Agreed the wording in the FAQ’s is somewhat sloppy and gives you ample reason to get your talons in a twist. Give the links I posted about FDA approval of medical devices a read may give you some real facts to regurgitate.
No problem arturo.
All I see of bald is:
'This message has been filtered, please adjust your filters to view'
I think I've seen at least a dozen today.
When will MED3000 be on the market?
MED3000 discussions are progressing well with regulators with an EU filing expected by the end of July 2020 and with positive dialogue with the US FDA providing optimism for a submission for a medical de novo device approval filing by the end of Q3 2020."
website needs to be updated re FDA.....or can they still submit a file for approval prior to the confirmatory trial?
Whoever wrote the answer to 'Did the Phase 2 results show placebo effect?' needs to be much more careful with their language. To suggest that the results shown by MED3000 in FM57 were due to the 'placebo effect' is bound to confuse people. I thought FUM were saying that MED3000 showed results that were significantly better than any type of placebo effect....now they are saying it was a placebo effect!!
A very poorly written answer IMO. Full of holes.
"...The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks"
That seems odd. This would suggest that MED3000 becomes more effective after 4 weeks of use.
Are they really trying to say that the P2 trial was too short (at 4 weeks) and MED3000 only kicks in after 4 weeks. That sounds slightly 'hard' to believe!! How are they going to market that?
"In order to see the full effect of MED3000 you must use for at least 2 months."
Doesn't exactly bode well for spontaneity..."Honey, give me a month & I'll be ready to take you to the moon!!"
NDR, it was you who 'suggested' - using your 'basic maths' - that the results of a trial size of 200 patients can be ignored.
I doubt FUM will want the FDA confirmatory to be anywhere near the 1000 patient size of FM57...they probably want to keep it to 200 patients or less, to keep costs down. Unfortunately if they do keep numbers down the results of the trial will be worthless...according to you.
The condescension is nearly always to be expected from BE. He always makes claims and counter claims without really knowing anything tangible about FDA process. Of course a smaller sample size will contain more standard error but FUM are not likely to design a trial to create meaningless results that are incapacabl of confirming anything and FDA have offered to assist in the procedural aspects of the design of the trial. I do not work in pharma and have never conducted a trail for the FDA but here are some bedtime reading links BE that expalin the FDA pocedures for medical devices.
PLease have a read before posting pure speculation and spin.
Many thanks Volatility for discovering the new FUM FAQ’s .
Well presented and answers a lot of questions that most sensible people might ask.
Unlikely however to satisfy those of an excessive loquaciousness who for whatever reason seem hell bent on trying to undermine Futura and its Board and more importantly fellow posters who have invested in the Company . Most probably a dissatisfied former employee unemployed and unemployable.
Rather sad that people should spend such a large part of their day with so little to do other than carp and criticise.
Have a good weekend all.
absolute drive b e I'm afraid,.they are saying nothing of the sort..
Phase 2 00 odd patients
Phase 3 1000 patients
Rather different samples
Hang on a minute...if they can get vastly different results just by 'selecting' the patients in a certain way and possibly phrasing the questions in a certain way that doesn't suggest that the results are very robust. Thye can get different results - one way or the other - just by tweaking the design of the Trial. Doesn't sound very scientifically rigorous to me....no surprise there then.
FUM's response leaves more questions than answers IMO.
"You are just trying to undermine everything about FUM (as usual). "
Joker, I'm just commenting on the mathematicial geniuses on here. Plus the seemingly dodgy logic supplied by FUM to a frequently asked question....asked by 'the volatile one'.
It will be 'interesting' to see how Prof David Ralph reacts to FUM apparently saying that his P2 Trial report contained mistakes and the data was flawed. Not a happy bunny I would imagine.
Baldy it is just a matter of time before Med3000 is on the shelves and the SP rockets to 108p and beyond. You are getting extremely desperate now, like holding on the edge of a cliff with just your fingertips by one hand. You are just trying to undermine everything about FUM (as usual). Take a break and come over to fantasy island where dreams do come true. You know you want to.