Member Info for bald_eagle

"As long as the efficacy of this formulation can be verified I don’t see this as being a stumbling block if it comes to market imo."
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NDR, agreed...if it works, it works ( have never said otherwaise). But it would be 'good to know' how it did work...in terms of optimisation of the product & to enhance IP. Hopefully FUM are undertaking such research...rather than relying on 'theories'.
I have a theory it's caused by fairy dust...lots of fairies in Guildford (allegedly!!)

Spiderman, apparently the 'placebo' wasn't a real 'placebo'....but nobody new at the time.

When will it get to market? The million dollar question.

Two likely routes. FDA & EMA...USA & Europe.
- The FDA require a 6 month 'efficacy' trial...which hasn't started yet.
- The EMA (EU) regulatory approval process has just started (Dossier submitted last month)...some are hoping for an 'answer' end of this year or early next year...others suspect it may take longer. Nobody knows for sure!

PS Others may wish to contest what I have written....for I am seen as quite negative on FUM. However facts cannot be disputed.

NDR, I agree, the 'bigger picture' is where it is 'at'. It doesn't explain why 'someone' at FUM needs to sex-up the blurb with unnecessary spin and half-truths....people in the pharma business can see right through the hype. Just stick with the facts IMO. If they have a product that can perform as they say it will then they don't need to make up stuff. What are they afraid of?....apart from the IP being a bit 'weak' at the moment.

- it would be good to know how MED3000 actually worked....for they may be able to enhance the product - seems unlikely they will have stumbled across the optimum 'formulation' by accident. They may also be able to patent the mode of action once they know how it works....I believe the patent application for MED3000 (former placebo) is for the 'formulation' only...but the patent is still pending on that!
- As Odysseus spotted the other day it appears that MED3000 (former placebo) didn't show the amazingly positive results seen in P2 trial that was seen in P3 trial....which seems a little 'odd'. But the confirmatory 6 month 'FDA' trial will tell us one way or t'other. Just need to confirm the scope of the new trial and whether additional funding (& how much) will be required....hopefully in September results.

Who is R.T.B?
There was some guy who was telling us all to sell up when the SP was circa 1.5p....when confronted he didn't make any sense. I think he has disappeared.

"An ED-specific DermaSys® formulation "
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I read that bit as well...it is just about OK. But the reader has to understand that Dermasys was/is 'usually' designed to be inert....it is formulated to transport the active ingredient (API) through the skin (no more, no less). A placebo by its very definition has to be inert...hence why they used the base Dermasys formulation (since renamed MED3000) as placebo in the P3 trial.
To attempt to describe MED3000 as 'specifically designed for ED' is false and misleading....it fools nobody expect newbies.
MED3000's application to ED was found by accident. Perhaps they should describe MED3000 as 'specifically designed by accident for ED'.
Awaiting company response.

"Thanks for telling us all nothing bald, yet again."
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So Volatility tell us, what have you got to bring to the table?

I reckon BoC has talked the most sense...there isn't enough information to make a call (at the moment).

PS I wasn't really interested in Parker & Manuel in the first place....apart from 'Nosey' Parker being a Thunderbirds character.
PPS Slightly interesting that Manuel 'lives' in Guildford (where FUM are headquartered).

"bald - or it could all be Mr Parker's own hard-earned £s"
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Or he could have found a pot of Lepruchaun gold....just to keep the Fantasy island brigade & fairy dust crowd happy!!

Really where Mr Parker (founder of CBDerma Tech Ltd) gets his money from is pure speculation on our part...that doesn't really tell us anything.

The 'fact' that Mr Parker & Dr Manuel may be in contact with Mr Barder is interesting but again doesn't raelly tell us very much. Although one would suspect that they have some sort of endgame in mind (being 'successful' finance men). From what Mr Barder said on Proactive they have decided on the 'easiest' way to get to market via a cosmetic route. But like anything, developping & marketing a new product from scratch isn't likely to be cheap.

Dr David Manuel Linkedin profiles shows 'Guildford, UK'....which may make him a drinking buddy of Mr Barder or an acquaintance at least. So it makes sense that BeaglePartners are associated with CBDerma Tech Ltd and FUM in some way. What they hope to achieve is anyones guess. I suppose they could be developping IP to sell on or perhaps they really want to get a product to market ...some form of cosmetic initially.

theItalian, thanks for the Parker info. I looked at the BeaglePartner website....they (Manuel & Parker) could be the backers behind CBDerma TEch Ltd. I'm not sure what it adds to our knowledge knowing who they are. It doesn't really tell us their intentions, resourcesor ultimate goal. They may or may not think $1m is chickenfeed....but like all businessmen they will want to see some tangible return on their investment. Obviously they may be getting grants that cover some of their initial investment, so they might not have as much 'skin in the game' as we think.

"I'm pretty sure Mr Parker's put some money into CBD research for a good reason."
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I might have missed it yesterday, but who is Mr Parker?....apart being a chauffeur of course!

BoC, I suspect you are wisely viewing CBD100 as the cherry on top of the cake. It may turn into something more substantial, but it may turn into nothing.

At the moment the risk to FUM seems minimal and the reward is unquantified....although it is a sexy thing to include in FUM's PR. Could all be hot air of course...like a lot of PR from AIM companies in general.

"....I'm sold (for now) on MED3000's potential but need something more credible on CBD100, otherwise it looks like an unnecessary distraction (which can be fatal for a small business). As long as they don't shift focus too much from the main event..."
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BoC, I see what you mean. You are concerned that CBD100 could distract resources away from MED3000 and delay it getting to market. Hopefully FUM management are aware of that danger. They can also sub-contract work to external contractors (such as Professor David Ralph)....but presumably at increased cost to themselves.

" looks like that number has been picked at random"
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BoC, I'm not sure what you mean. The $1m was the maximum amount allocated by CBDerma Tech Ltd for the work undertaken by FUM. Presumably they would be 'happy' for it to be less than $1m but not to exceed it.

I'm not sure we need to know where the money comes from....unless it is drug money!! (Russian money would be acceptable I expect). As long as the money keeps flowing to fund FUM's development then happy days. Worse case if FUM are asked to contribute towards future development in cash terms....this would have to be factored in for the fund raising.

"Who’s Responsible for the Safety of Cosmetics?

FDA does not have the legal authority to approve cosmetic products and ingredients (other than color additives) before they go on the market. We also do not have a list of tests required for any particular cosmetic product or ingredient. However, a manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labeling or in the customary or expected way. FDA can take action against the manufacturer of a cosmetic on the market if we have reliable information to show that a cosmetic does not meet the legal requirement for safety" [https://www.fda.gov/cosmetics/cosmetics-science-research/product-testing-cosmetics]

FUM & CBDerma Tech Ltd will need to undertake testing to ensure any cosmetic product is safe...especially in the USA where people like to litigate!!

"Initial development costs are expected to be in the region of US$ 1 million and will cover all development costs incurred by the Company during the next 15 months in order to develop and optimise a DermaSys®- cannabidiol formulation as well as establishing early ex-vivo proof of concept studies likely to include certain disease states most suited for local or regional (non-systemic) topical treatment such as pain relief.  The Company does not expect this project's initial development to have any material impact on cashflow as Futura's financial share of the project will be delivered from its expertise and existing internal resources."

So the initial $1m is budgeted to last until approx the end of the year. This was intended for ex vivo testing. So any trial on real humans will presumably require some additional funding, possibly early next year.

"Mr bald slowly slowly it’s a like making love."
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Jonah, the Bald_Eagle is more a 'Wham ! Bam ! Thank you Ma'am !' sort of a bird.

Amanda, thank you so much for re-posting my comments...you really are a cut & paste demon. Keep up the excellent work.

"All Intellectual Property will be owned jointly by the Company and CBDerma Technology Limited."

The share buy-back continues...25,000 shares yesterday at 120.9p (seems very low).

More of a concerted effort today....a slow burn then!!