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State of play

lse:fum

#1

A summary of the state of play…

  1. A licensing deal in the interim period has still not been ruled out, however in order to maximise share-holder value it would be necessary to wait until phase 3 results
  2. If the part 1 of phase 3 results turn out to be highly statistically significant, there is no need for another Phase 3 for EU approval. However the part 2 of phase 3 would still be needed for approval for FDA (primarily because they would like to see some population from the USA make up the trials)
  3. It seems main obstacle was the “significant upfront” FUM was insisting on in order to hand-over control of development of MED2002 for phase 3. This may explain why the clinical trial application seems to have been submitted later than what would normally be expected.
  4. It seems the Pharma’s were reluctant to give a significant upfront based on phase 2 data. Therefore in order to keep the control it was necessary to progress MED to phase 3 in-house and not sign a deal at this stage. Given what happened with CSD I have to support this.
  5. Risk 1 – One risk is MED does not show efficacy. This is countered with the fact that it has already shown efficacy in the 0.2%
  6. Risk 2 – MED only shows efficacy in the mild and mild to moderate. This is countered with the fact that even as a medication for mild and mild to moderate it still represents a significant opportunity. It also does not stop over the counter sales as MED should maintain the safety profile it has shown to date.
    This is also countered by the PK Study data which has shown increased levels of GTN in the blood stream as dose is increased but more importantly within the same time frame as the 0.2% GTN
    A further counter argument to this is other medications have different strength levels. Historical Studies completed by FUM have considered doses less than 0.1%. They found at very low levels there was no effect but as concentration is increased they started seeing increased blood flow, supporting the theory of increased GTN concentrations working/showing more efficacy in the other patient groups.
  7. Risk 3 – MED at higher concentrations is not safe – Vitaros which gave a long list of severe adverse events was approved by the EU and other countries. MED has shown a good safety profile to date.
  8. If JB and family own significant portion of the company you have to believe they are working to maximise value for all of us share holders…
  9. Part of the phase 3 study is open label

Whilst the setbacks have hurt us all- we have to believe we all made the right choice… and there is value to be had from investing in Futura Medical…we are on the brink of getting phase 3 results (brink in terms of pharma world)
We all wanted to make a quick buck but let’s all think a bit longer term here…Good luck to all those still invested and those considering investing, do your own research and good luck.


#2

Great synopsis. Many thanks Aberdeen.

It seems that this FUM group have re-formed for (hopefully) one final tour.

Here’s hoping…
GLA


#3

Just one more point if I may.

Fundraising - we know some parties are still in discussion. They realise the company was not bluffing when it came to carrying out the phase 3 trials themselves.

I believe the management are working both scenarios

  1. Work out alternative fund raising requirements through other means…
  2. See if the existing discussions bear fruit when it comes to upfront payments etc

Probably wise to keep both options open and progress both of them


#4

What I haven’t found (maybe I haven’t been looking hard enough) is any indication of sales from blue diamond, however small a contribution it may be. Am I missing something or do I just need to look harder?


#5

JB was wearing a new Ralph Lauren shirt!!! He is always confident whilst wearing those shirts, especially in combo with a crazy tie! :slight_smile: The man knows the path to walk on to…I also wantend to make a quick buck, but instead have a paper loss of about 50%…but I am holding on to every share I have…of all the biotech companies in my portfolio this one has the highest risk/reward…a-not-for-little-boys-stock!!!


#6

If you download the PDF from the interim report it gives details of a financial income for the 6 months, it gives a figure of £9429.

I’m guessing this might be from sales of blue diamond as they don’t have any other products that can provide income at the moment.

Someone tell me if I’m completely wrong because it is just a guess.

Good to see this board is back, Aberdeen you summed it up really well. And Pharmatom with a bit of banter.

As Derick Trotter once said this time next year we’ll be millionaires (maybe a bit longer with Fums deadlines)


#7

Good summary, Aberdeen.

Markthemango1 - the finance income of £9.429 will be interest received on the bank balance, a paltry amount but interest rates on deposits are extremely low.

There are zero sales of anything. Blue Diamond has been out of stock for over a year now (per their website - scroll down to the bottom) ……

http://www.bluediamondcondom.nl/#!/buy-now

………… and the only other partner who have launched, Kabey, again sold out over a year ago and rather than use TTK as a supplier, have been waiting for the German manufacturer to obtain the 2 year shelf life approval - check out the German flag on the “Manex Super” (the CSD condom) on the condom box ………….

http://kabey-pharma.com/index.php/manex/condom_range


#8

Thanks for the links Tony, and yeah it definitely is interest I’ve just had chance to look through properly, don’t know how I missed it.