Member Info for bald_eagle

Some excellent research by NDR & theItalian (if you don't mind me saying so). It is refreshing to have some information from reputable sourcse to base our assessments of FUM...rather than wishful thinking.
Hopefully what you have found has made you more confident in your investment. Either way it fills in the gaps in our knowledge.
PS I suspect the notified body wouldn't have been able to give much of an assessment of FUM's data in December because the technical file wasn't submitted until July...I suspect any level of confidence FUM had would have come from their special advisor(s).

Yep, Edelman was a tool.

Probably of equal note to the actual numbers is the possibility that Altn are going to release a quarterly production update....which presumably shows a certain level of confidence in the numbers going forward.

theItalian, thank you for your thoughtful response.

I was not aware that FUM had suggested that the FDA were more likely to require additional data than EMA. If that is the case then it would be encouraging for investors. I do know that FUM have sought specialist advice for the EMA submission (& presumably likewise for FDA)....so it is possible that their consultant gave then confidence in the technical data they submitted to EMA would pass inspection. However they wouldn't have been able to give a cast iron guarantee...unless it was 'almost' a guarantee!!!

Ultimately we will have to wait for the fat lady to sing...but enough about Amanda.

theItalian, thank you for your thoughtful response.

I was not aware that FUM had suggested that the FDA were more likely to require additional data than EMA. If that is the case then it would be encouraging for investors. I do know that FUM have sought specialist advice for the EMA submission (& presumably likewise for FDA)....so it is possible that their consultant gave then confidence in the technical data they submitted to EMA.

In h1 2018 they:
milled = 182,800 t
grade = 1.72 g/t
recovery = 83.65 %
Gold poured = 8461 oz

In h1 2020 they:
milled = 186,900 t
grade = 1.5 g/t
recovery = ? %
Gold poured = 6990 oz

Conclusion: They need to get the grade up...hopefully by the new equipment. A long way to go.

"I you realising I was right with my 2 weeks."
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That 2 weeks is becoming the longest 2 weeks in the whole history of the universe. Are you working on Martian time?!

I do wish people would stop putting arbitary timescales on things...the SP will reach 108p on 1st APril....10-12p in September...whatever Jonah said 2 weeks ago (not sure of he did put a figure on it).

The SP will reach what it reaches, whan it reaches our targets we can buy/sell/whatever....although the Fibonacci crew may beg to differ.

"....and with potential now building, I struggle to see why we haven't seen more upwards movement on the SP"
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BoC, you really don't know?!

In 3-4 weeks we get the interim results. Which may or may not contain additional information on the requirements for the FDA 6 month trial. This may prompt some form of fund raising.

Also the EMA application requires the following: "Submission of Technical Documentation (TD) which includes sufficient efficacy, safety and quality data"

This seems very similar to the FDA 'data sufficiency' requirement. It wasn't something I was personally aware of until quite recently. It is the big hurdle they need to jump (IMO).

As I have mentioned before it would be good to know ASAP if EMA require additional data and they could incorporate any requirements into a joint EMA/FDA trial. Investors will be hoping that EMA will be 'happy' with the technical file as submitted (obviuously).

theItalian, what is your take on whether EMA will require addittional data like the FDA?

One positive from todays RNS. The EMA notified body is working despite the pandemic and replied to the QMS requirement quickly. Whether the technical requirement is as fast is unknown...hopefully yes!

"The more significant bit in here for me, is the bit about FUM appointing specialist advisors to support commercial negotiations - should be music to our ears - JB now understands that FUM would benefit from support in this area"
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BoC, yes I agree. It was 'probably' more interesting that the main thrust of the RNS. It is difficult not to speculate what it could mean:

"Futura has now appointed specialised corporate advisers with international experience to facilitate commercial discussions with potential licensing and marketing partners."

It is 'probably' a realisation that Mr Barder needs specialist help to negotiate complex agreements with potential Pharma partners...as FUM have found in the past, a badly worded contract can store up problems for the future.

KDonkey, it is an honest appraisal. The QMS part of the requirements was always going to be easier than the 'data sufficiency'...if you think otherwise then please explain why?

If they can get the 'data sufficiency' approved then that would be significant. But you seem to have a different opinion.

Are people really 'relieved' that FUM passed the QMS test....it should be a relatively simple thing to pass. All companies need some form of QMS nowadays. Do you really have such a low opinion of FUM's management that you thought they would fail? Even I knew they would pass QMS....'data sufficiency' is another matter!!

I don't know if you read the 'explanation' FUM recently posted on the website FAQ section on why P2 trial had different results to P3 trial. I wonder if you had any comments - as an scientific minded person. Here is the information (I beleieve it was in response to a direct question to FUM made by Volatility ):

"Did the Phase 2 results show placebo effect?
The Phase 2 study did show a placebo effect which was expected as the massaging of gel into the glans ***** will cause some sexual stimulation. However, the effect was much lower than experienced in the phase 3 study. We believe the greater effectiveness in the Phase 3 study is a result of two main factors.

The study had far greater scale than the Phase 2 study. The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks. Also 61 sites were used versus 4 sites in the phase 2 study which would reduce the impact of natural variability occurring between test sites. Moreover, 3792 versus 984 intercourse attempts were made which is a much larger and more reliable sample size to study the effect.
We learnt from the Phase 2 study that enhancements to the subject recruitment process and pre-screening were required and therefore much greater emphasis on this was placed in the Phase 3 study with very strict compliance to the inclusion and exclusion criteria. We also placed greater emphasis on patient training and therefore compliance to the treatment regimen.
Therefore, we have concluded that in moving from a small Phase 2 study to a large Phase 3 study that the placebo effect was far greater than first indicated and presents an exciting opportunity in its own right without the inclusion of a drug substance."
[https://www.futuramedical.com/what-we-do/products-faqs/med3000-faqs/]

If they could pass the QMS (Quality management) test then they really would be in trouble. I 'imagine' it is a paperwork exercise (much like ISO9001), which confirms they have procedures in place to manufacture a 'quality' product. Hopefully most companies have such procedures in place...and are following them.

The second part of the testin 'probably more tricky: "Submission of Technical Documentation (TD) which includes sufficient efficacy, safety and quality data"

If the EMA are 'happy' with the data sufficiency - unlike the FDA who requested an additional trial - then that would be a major achievement...and really warrant an RNS.

BusterHD, you seem to be losing the plot m8.

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"
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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!!

"The sample size may well be smaller in FDA confirmatory trial but the time scale is considerably longer, six months."
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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
etc etc

So nothing to do with the TRMR buy-back scheme at all...how confusing!

It would appear that a company called JB Capital Partners LP from Armonk, USA now have just over 3% invested in TRMR....whoopee!!

I wonder if that is gdog? Haven't heard from him in recent days.

Same sentiment back at you m8...who gives a monkeys what you think about RB (or anything really) ?

"
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."
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website needs to be updated re FDA.....or can they still submit a file for approval prior to the confirmatory trial?