All PhaseIII trials do not end successfully. Take these 2 recent...

All PhaseIII trials do not end successfully.

Take these 2 recent examples from fiercebiotech.com

"Tranzyme Pharmaceuticals, another biotech which recently went public, is demonstrating just why biotech investors are so skittish about development-stage companies. Its shares blew up this morning, alongside Anthera's, after the biotech said that its lead GI drug looked no better than a placebo in Phase III. A second, mirror Phase III is continuing, but with the treatment failing both primary and secondary endpoints, Tranzyme says this morning that it will halt any further NDA work underway as it shifts focus to an oral program."

and

"Anthera Pharmaceuticals may be regretting that it went ahead with its IPO in 2010. After the market closed Friday, the biotech reported that a late-stage study of its lead drug had to be halted after the independent monitoring board concluded that the hope of establishing efficacy was futile.

"This is a very severe blow. Theoretically, they can do another Phase III program once they see what went wrong in this one. But, whether they'll have this opportunity is unknown," Wedbush Securities analyst Duane Nash told Reuters."

EMS is almost half way thru PhIII trials of the arTiMist artemether-sublingual-delivery-platform. The drug is not on trial here (it works a treat) the delivery system is.

Given that the system has previously shown stability (un-refridgerated) for up to 2 years in tropical environments it's a pretty good indicator that the system should work for malaria affected communities in remote location without medico personnel.

PhaseIII risks for EMS are:

-Protopharma have ownership of the PhIII trials and therefore EMS is something of a by-stander (albeit with a significant vested interest).
-If the wet starts as expected and recruiting of the final cohort of patients occurs in Ghana and Burkina Faso as expected then Phase III should be completed in this African wet season.
- Tanzania regulatory approval has been held up and best way fwd to my mind is increase the recruitment numbers in those locations currently recruiting (but that will be PP's choice)
-The delivery system needs to be shown to work after analysis of the results.

The next stage is marketing approval - how long that takes I'm unsure, however with this done then EMS have a tidy package ready to go back to the market (who SC has already met) and offer up the package for trade sale.

We aren't derisked as yet but we are getting towards the pointy end of this totuous road

bluebush