Member Info for bald_eagle

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"
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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.

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). "
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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.

"Anyone who has done some basic maths knows that the larger the sample the more robust the statistical result. This clearly bodes well when it comes to confirming the efficacy of MED3000 in a new confirmatory trial for FDA."
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NDR, your 'basic maths' must be really basic....the P2 trial was a serious size. The results should have been similar. FUM have sort of admitted that by suggesting there were flaws in the P2 trial....flaws that they 'fixed' in the P3 trial.

The confirmatory FDA trial could be quite limited in size (least burdensome approach)....according to your 'basic maths' it could well deliver results far differesnt to the P3 trial (because the number of patients is significantly smaller).

Hopefully there are investors on here with 'advanced maths' who can tell us what FUM's statement really means!!

What does that mean in English?

Oh...you do know that 'retired' is one word?

Personally I have found RB to have a fairly balanced view of the Altyn's prospects...but maybe that's because they coincide with my own to a large extent.
Altyn has potential - and they are in the best place they have ever been - but there are risks. Not really a share for widows & orphans...unless in a small way, where one can afford to lose it all.

When is a 'gauarantee' NOT a 'guarantee'?...when it is 'almost a guarantee'.

Like saying that Amanda is 'almost' intelligent!!

"Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended....
The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device....
On 23 April 2020, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period of the Medical Devices Regulation by one year - until 26 May 2021....
During the transitional period, manufacturers can opt to place medical devices on the market under the applicable EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) or under the new Regulations if they fully comply with these."
[https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices]

I'm not entirly sure what all this means...but it could be that FUM have been lucky and are able to opt for an easier regulatory path. Whether this will require a 'conformity assessment' is unsure...doesn't 'conformity assessment' sound suspiciously like the FDA 'data sufficiency' test?!

But who is RTB?

Who is RIP? Any relation to RTB?

" if i have understood you correctly,expressing concern that the actual effects of FUM3000 might be disappointing to users and might lead to poor repeat ordersand this was the elephant at that point. if i am correct is it still the same elephant or has another one (perhaps even bigger and more menacing) entered the room?"
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theItalian, yes still the same elephant....elephants don't disappear that easily....unless pink. I have been hunting Tigers since so have become distracted. But Oddyseus has reminded me that I have unfinished business...time to dig out the big guns.

PS I think I mentioned that my elephant has shrunk somewhat since MED2005 became MED3000...but I think it may still exist. Just got to catch the bugg3r.

"how come you know how MED3000 works and nobody else does? You said, "The Dermasys mode of action... is based on evaporation..." "
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Bucolic, becasue I am the 'Eagle'flying high!! I can see things that others may miss.

No seriously, you should know this. Dermasys was the long standing 'base' technology upon which all FUM applications were built...it (the name) is trademarked...but not patented. Dermasys in the FUM literature (paraphrasing somewhat) was described as the transport of the active ingredient via the suitable selection of base solvents through the skin membrane using evaporation to create a superconcentration of the active molecule, forcing it through the skin.

MED3000 is 'obviously' different because there is 'apparently' no active ingredient....it works (according to the 'theory') in a totally new way (some cooling/heating cycle). So in that respect MED3000 and Dermasys have parted company....or so the 'theory' goes!!

Personally I believe it's 'tinkerbell' dust...

"Baldy, you said that having a patent on the oil in a car, but not on the car itself might be a bad idea, "
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Bucolic, I don't believe I said that...patent on the formulation would be OK, patent(s) on the vehicle would be better.

People are always amazed that Dermasys isn't patented. The patents are on the 'formulations' for each application. The Dermasys mode of action itself isn't patented...because as theItalian alluded to it is based on evaporation, which is a natural phenomenon & therefore 'probably' cannot be patented.

But MED3000 is different...the mode of action was unexpected and could open up the possibility for patents on Dermasys itself. Which would be the holy grail. But first they need to investigate why MED3000 actually works. But if nobody but me is interested...then that makes me happy!

I still have my elephant to go hunting.

"Does anyone know the exact mechanism for BE’s posts?"
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All based on facts.

FUM don't really know how MED3000 works...FACT
FUM have a theory. on how MED3000 works...FACT
FUM need to know how MED3000 works before it can be sold....FAKE (never suggested any such thing)

Would it be better if FUM knew how MED3000 worked (mode of action)...YES (I think we can all agree on that). Could that knowledge lead to an improved product and even better IP....YES (I think we can all agree on that as well).

SO what is the problem?..I haven't said anything that any investor isn't thinking. WOuldn't it be good if FUM actually knew how MED3000 worked. It would only make MED3000 more of an asset....which would be good for investors.

"How about telling us about the elephant in the room that you keep alluding to?"
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Bucolic, people weren't really interested. It's a theory I have but hasn't been investigated propely. Not a fact, so I cannot promote my theory without substance...it wouldn't be appropriate.

Paracetamol works....we know it works, it is cheap and effective. The NHS gives it for everything, like sweeties!!

I presume they have theories on how it works but nobody is going to pay to investigate. It is cheap & widely available. There is very little point in trying to enhance something that works effectively & cheaply. There wouldn't be much point in getting patents on something sold so cheaply.

MED3000 is different. They might be able to get IP on what they find. It also might lead to methods for enhancing the actual product.

Also a competitor might do the investigation instead and find something that they can patent, leaving FUM with a patent on the 'formulation' of MED3000 but the competitor with the patent on how it works....I suspect one is more valuable than the other in terms of IP. Like having a patent on the oil in the car but not the patent(s) for the car.

But if you guys & gals are 'happy' with that possible scenario then that's OK too.

No scaremongering intended on my part....just stating a fact and highlighted two benefits of understanding the mode of action.
If FUM aren't attempting to understand better how MED3000 actually works then that could be a mistake (but I am sure they are). Knowing how MED3000 works could lead to an enhanced product and also additional IP....both very worthwhile aims. But I suppose we may have to make do with Ken's theory.

You little minx you. Just looking at your posting history and you have been 'involved' in FUM in quite a big way...even speaking to Ken James in person (have you washed since?!). You 'probably' know more about FUM than any of us...definitely Amanda.