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I take your point comeonvog

The impression I got was it was not all down to 50 percent more in NPV.

It was to do with control too which in my opinion carries far greater importance.
Handing over control now in exchange for an upfront payment with “promised” future payments is a big No No! We’ve been there before and where did that lead us?

So the direction they are taking might have pissed off a lot of folk but I for one, agree with the companies decision.

Thanks vigneron53

The summary of the webcast (which I could make out)

Out licensing/doing a deal now would have meant we lose some control over the product which could have hurt us in future (different pharma's have different agendas)

- He is adamant that this was the best way to maximise share holder value

- market access and engagement programme with opinion leaders - Does anyone know what this is

One other point was made. That point is even IF phase 3 results repeated phase 2, i.e. MED showed efficacy in mild and mild to moderate, it could be positioned as a treatment for mild and moderate ED cases for both prescription and over the counter cases i.e. there is still value to be had. In other words, even if the 1 billion dollar turned out to be a 500 million dollar opportunity (treating half the number of men) there is still value to be had , much greater than what the share price is showing right now!!

Oilovlam I said approximately linear and that’s why I gave a range. After checking the PK results the range I gave is correct. Therefore I do not need to add the word “probably” in front of the timescales I am referring to for each of the concentrations. Hope this clarifies.

oilovlam - are you suggesting I rephrase
""In other words, the 0.6% dose achieves the peak concentration of the 0.2% dose in a third of the time (sometimes less than a third of the time) whilst the 0.4% dose achieves the peak concentration of the 0.2% dose in half the time (approx.).."

to
"In other words, the 0.6% dose probably achieves the peak concentration of the 0.2% dose in a third of the time (sometimes less than a third of the time) whilst the 0.4% dose probably achieves the peak concentration of the 0.2% dose in half the time (approx.).."

That would be misleading other investors, something others are doing on here. I do not wish to be a part of that.

My statement is not "probably". I have had the timings confirmed from the PK Study, therefore I will stick to my original statement which is accurate and not misleading.

Rhodi - I understand your frustrations and you are entitled to this.

I do have one point though.
For those that attended the AGM, there were some who came back with the impression that Futura Medical would go it alone for phase 3 trials. One such individual is Fx....on ii and his post should still be there.
He clearly felt they were prepared to go it alone if they were unable to get the numbers they wanted or in terms they wanted. Whilst not all of us are able to attend AGMs (me included) perhaps we should have made more of an effort.

As for punchy numbers - When licensing discussions take place, ball park figures are mentioned at the beginning but the range (upper and lower) is so wide. It’s only after all the due diligence has taken place that the companies come up with a number that could sit at the lower end, middle or at the high end of that range. Depending on the assumptions an individual company makes this range can be huge.

So clearly if a company or companies are coming back at the lower end of the range, you can understand where that fx chap was coming from when he noticed FUM May well go it alone.

Are you aware of the term stage gate processes? It’s what companies follow when they evaluate potential opportunities..

Hawk head
If you imagine there are two groups
Group 1 - Contraindicated patients
Group 2 - Patients that are able to take PDE5 inhibitors (viagra, Cialis etc)

For group 1 - I agree that the onset claim is not really required as they are not really taking anything else or do not have anything else that works and is convenient.

For group 2 - I think the companies would need a valid marketing claim to “attract” them or to “switch” them from using their existing treatment to MED2002. This opens up a world of opportunity that can’t be underestimated.

Granted, Group 1 (10 to 15%) is a big enough market size but it’s still much smaller than the remainder 85 to 90% market size.
So I think they do need to break away from Placebo for the “onset of action” claim but using the higher doses which effectively enables more GTN to be absorbed in a shorter time frame will hopefully allow this. The science says it should. We wait in the meantime.

Good on you hawk head.

Well done

All investors.
Yes agree that phase 3 has to show more in terms of speed of onset

However whilst nothing is guaranteed I’d ask all investors to please consider the following.
As the dose was doubled or tripled, the GTN levels in blood plasma also doubled or tripled in approximately 10 to 12 minutes for all the doses in the PK Study. Accordingly this points to an approximately linear rate of absorption. Therefore if it’s approximately linear, then since the peak concentration for the 0.2% was achieved in 10 to 12 minutes, this means the 0.4% dose achieve the concentration 0.2% achieved in approximately 5 to 6 minutes and likewise the 0.6% dose would achieve the peak concentration 0.2% achieved in approximately 3.5 to 4 minutes….
In other words, the 0.6% dose achieves the peak concentration of the 0.2% dose in a third of the time (sometimes less than a third of the time) whilst the 0.4% dose achieves the peak concentration of the 0.2% dose in half the time (approx.)..

The above should (hopefully) increase the probability of hitting the onset of action claim.

Comeonvog- That's what I have been saying for those who have taken the time to read up on the phase 3 design.
Part of the phase 3 design is blinded and some of it is open label (the patients using 0.6% open label part)

Martinelwick - Spot on

The speed of onset is one factor and efficacy is another. People have jumped to the conclusion that you state... but hey ho... we are where we are... those able to distinguish the above and see value will benefit

I think all of us are in agreement.

Essentially what we are all saying (I think) is the product works, but a pharma company would also like to make certain claims and more work needs to be done in phase 3 to allow a partner to make that claim even though the product may well work fine.

In Mild patients 54% had onset within 5 minutes. 82% within 10 minutes

The relative percentages across all patients are 44% within 5 minutes and 70% within 10 minutes, the same as Placebo.

So in summary even though the mild cases were quicker, we have nothing to compare it against. (i.e. placebo data for mild group)

Just to be clear - there is no removal of the 5 minute claim. What was said, was in order for a potential partner to be able to use that claim, it needs to be substantiated against placebo during phase 3 for all patient sub groups.

Oilovlam,

You are correct and raise a valid point.

It is not clear from the data they have made public whether MED2002 differentiated itself from Placebo for the mild patients. If MED2002 differentiated itself from Placebo for the mild patients then increasing the concentration may work for the more severe cases. If the mild subset of patients were not differentiated from the severe cases when it comes to this point, then increasing the concentration will not work... Judging from the interview, they seem to think the higher concentration may work which may suggest the mild patient group did show some differentiation from placebo when it comes to this...

Nevertheless, if a company is able to make the marketing claim it would seriously increase the value for MED... If however it is not able to make the claim, then the value is obviously lower even though it may well work...You can understand why pharma companies want phase 3 data to see what claims they are able to make which in turn affects the price they are willing to pay..

Good point oilovlam

So in summary what do we know.

- The PK Study showed as dose was increased GTN levels in blood plasma increased
- GTN is converted to nitric oxide and therefore GTN higher doses would likely have the impact of higher nitric oxide levels
- The contra-indicated market is approx 12 to 15% of the market and this should be the primary target for MED2002.
- Even if the 5 minute claim is not able to be made, the above population 12 to 15% have no other alternative
- Vitaros was able to command several millions despite the mode of action involving a plunger device into the Urethra
- If all else fails and phase 3 shows MED2002 to only be effective in mild and mild to moderate at the higher doses (essentially the same as phase 2) - the FDA would only approve it for mild and mild to moderate cases of ED whilst at the same time the 10 to 15% of patients that are contraindicated would still be prescribed MED2002 subject to phase 3 where this population group will be included. What I am trying to say is the product still has value to it even if the results from phase 2 were repeated, something that is being overlooked right now as the sentiment seems to be at the absolute low point
-Part of the phase 3 study is open label whereby both the researchers (Futura Medical) and patients will be aware what they are taking and therefore feedback on using the product will be open (since this part of the study will not be blinded). The blinded part of the study will only be unblinded at the end. Bear this in mind. Granted they will not be able to compare the open label part of the study to placebo but nevertheless it should give some feedback prior to the end of phase 3.

I am simply stating the facts which I admit can be drowned out with the current hysteria around no licensing deal. I am saying that in my humble opinion there is value to be had for those that can see beyond the current sentiment.

Good luck all

absolutely notrac

notrac - please bear in mind N4Pharma PK results did not show an increased concentration of the active in the blood plasma as dose was increased., i.e. it would not work!

Far from the case over here. It's the total opposite as far as the PK Study is concerned for Futura Medical

Hello notrac

The numbers quoted are for blood plasma concentrations of GTN - which in turn gets converted to Nitric Oxide

Hi oilovlam,
The placebo in this case is just the gel without the active ingredient (GTN) i.e. a gel made up of alcohol and other ingredients that would evaporate off..(eventually)

The 0.2% GTN MED excelled (over placebo) when it came to hardness of erection and satisfaction of sexual experience. Both these questions are part of the overall assessment used to measure the EF scores.
The link in hardness and therefore satisfaction of sexual experience is hopefully because of the extra nitric oxide being produced. Where it was unable to show any significant improvement over placebo was in the "onset of action" when averaged across all patients.

Increasing the dose of GTN should increase the Nitric oxide being produced which should in theory help across all areas being analysed, especially the hardness of erection and satisfaction for the more severe cases of ED.

Hope this answers?