A summary of the state of play…
- 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
- 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)
- 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.
- 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.
- 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%
- 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.
- 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.
- 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…
- 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.