Member Info for bald_eagle

"Call me obtuse....I just now figured out what you meant by your joke."
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Even allowing for a different time zone that took some time for the penny to drop...all that Russian dope in the water supply must be working. Can we have some...it must be good stuff.

Novichok in Salisbury don't count!!

It could all end tomorrow by the Assabayeu family offering 1.0 pence per share.

Don't get too carried away...there's a lot that could go wrong with a gold mine in Kazakhstan.

There must be something in the water

"I stand corrected on MDR their submission means we could get in on MDD. Stull a bit of a sh##storm though as notified bodys adapting MDR process"
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BackInBlak, I don't really understand the difference between MDD versus MDR submission. The new regime is MDR and it takes effect from May 2021.

But presumably FUM will have to comply with the MDR regulations at some point, because they will be selling their product in the EU.

"Certainly, for the manufacturer who produces medical devices for the EU market today, and who wants to continue supplying those devices beyond May 2021, complying with the new EU MDR will require a lot of additional work."

I suppose the switchover from MDD to MDR could intruduce delays in the regulatory process at their end...and don't forget that the coronavirus pandemic could also introduce unexpected delays. So EMA regulatory approval could take longer than some people anticipate.

So the 'best' Jonah can come up with is some Fantasy about a big pharma company swooping in and paying big bucks for FUM. Enabling FUM's management to have a happy retirement and investors to see a Fantasy pay day.
All this before any regulatory approval and even before we even know how MED3000 actually works and before the product has been properly tested (via the extra FDA trial).
Pure 100% Fantasy island stuff. Loving it!!
All this from someone who didn't even know that the FDA have requested a 6 month trial of the wonder product MED3000.

Frank, you must have caught Jonah's fact blindness. Please re-read and try to absorb the information contained in the 14th July RNS....it is written in plain English (even I can understand it):

"This additional data will require a further small clinical trial where patients with ED will receive MED3000 for a six month treatment period. "

Is that so hard to understand?!

gdog, hopefully you get to vote to re-elect him in November.

People either love or they hate Trump....there is no middle road with Donald. I reckon that's the way he likes things.

Bucolic, you are too much of a gentleman. Spoon feeding him like a baby isn't going to teach him to do basic research...just make him lazy.
It is rather scary - but to be expected - that people like Jonah don't know the first thing about the companies they are touting.

"not really accurate to say fda approval has been delayed"
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theItalian, they cannot get FDA approval until they completed the additional trial (which requires 6 months worth of data I believe)...so any FDA approval is delayed until then (at the very earliest). Some people may have been hoping for quick FDA approval (a matter of months perhaps!!) but now FUM have to get the new trial out of the way first...hence the delay. To argue that an additional trial will not have lengthened the FDA approval process seems odd (to me).

PS The results for the additional trial could be a year away....several months to arrange the trial, then 6 months of data collection, then some time to collate & analyse the data into a report. Never mind the impact of Coronavirus on the whole thing.
FUM thought they were immune to the impact of Covid-19....maybe not.

"Where does it say they need another trial please stop giving false information."
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Jonah, for once I am gobsmacked. Your ignorance is monumental.

"..but FDA approval, maybe the boomers at the FDA will see this as a superior solution to fix their erectile dysfunction"
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Frank, hadn't you noticed!!...FDA approval has been delayed until they have another trial (at the very least). How long it takes FUM to arrange that trial and even the scope of the trial are as yet unknown. Perhaps some news on that in September....or perhaps Mr Barder is going to be talking 'punchy numbers' again!!

Bucolic, that must be a joke...what's the punchline?

It must be April 1st....no, cannot be April Fool's day...FUM's SP isn't 108p!!

Took me a while but I got the joke in the end. Quite funny really.

A comment on how polarised the USA is at the moment along political lines....is this something Trump is responsible for or has he just exacerbated something that was already there? A serious question for our American chum.

There was a commentator yesterday who suggested that Americans might like a 'background President'....Trump seems to be a person who only has one speed...110%. It must get quite tiring after a while for everyone around him.

Oh, you meant Jonah333...phew!!

There are quite a few who post random junk about 108p next week (and such stuff). Background white noise....just ignore it. Or poke fun at them if you've got the time and/or the inclination. 'Luckily' I have plenty of time.

"stop listening to this brainless guy"
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Please be more specific. Your post could apply to any of us....even me!!

gdog, what's the deal with Hydroxychloroquine and the Trumps....does the Trump family trust fund own the company that makes the stuff?

Heard yesterday that the US federal government have a million doses of the stuff. More fake news from the BBC...& that is just Trump's personal supply!!

It's gonna be interesting to see what happens IF he tries to delay the November election.

re. placebo.

Will one of the regulators (EMA or FDA) require MED3000 to be trialed against a truly inert vehicle (some sort of verifiable placebo gel). Currently FUM are only presenting data that shows a positive reaction but without the true negative of a real placebo, how can the regulator know if the possitive effect actually was due to MED3000 and not some other phenomenon (the sexy nurse effect!!)?

For a while they thought that MED2005 - with its active ingredient - was causing the erection. But they were wrong. What is to prove that FUM isn't wrong again? And will the resulator(s) require extra proof...or is the current trial data sufficient?...even though MED3000 wasn't actually trialed against a placebo.

PS Obviously the FDA want additional trial data but at the moment we don't know if that trial is going to require a placebo (or inert vehicle).

"yes, my theory is that given the 'punchy numbers' episode etc that JB got loads of stick and that forced the change"
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I suspect you are correct. Personally I would never abuse someone like that...but when people have lost a bundle they aren't always as polite as me.
He seemed to almost disappear for a while...and Ken James seemed to take the limelight (all the proactive interviews). But recently Mr Barder has been making a bit of a comback...he even seemed quite excited to be in negotiations again (his forte apparently).

When is a placebo not a placebo? When it's a vehicle!!

It is something I don't really understand. FUM have test data for MED3000 but they don't have any comparison data against a real placebo. So how can regulators (in EU & USA) allow them to make the claims? To say for sure that the data is valid I would expect any trial to include a placebo...but do regulators need to see a real placebo negative result before they trust the MED3000 data. I'm not sure if the FDA additional trial will include a real placebo...the 'least burdensome' approach may not require one.

Perhaps Odysseus has some thoughts since he is a pharma boffin.

Good progress.

In the 'good old days' you could send an email to FUM at 8am and get a response from Mr Barder within the hour. But a couple years ago - when FUM SP collapsed - they started employing a PR company to filter the messages. From the couple of times I have tried they send out a standard reply..."Market sensitive information" claptrap. Good luck anyway.