Hi jci310, I certainly understand your position here, I am equally frustrated by the lack of progress on the PhaseIII trials.
I'm not trying to make excuses for EMS, that should be Stephens' job to pacify expectant shareholders, but to my mind there are a few factors which were always going to complicate these Phase 3 trials.
The first is that malaria is seasonal and whilst your quite right 150 patients is a very small trial, outside of malaria season the trials stop.
Secondly, arTiMist is designed for complicated (gastrointestinal) malaria cases. If the trial design mandates this type of patient is required (ie also have typhoid for example) then there will be an even smaller set of potential patients to choose from.
Also, the trial design was originally across 4 African countries. In Africa, things happen a lot slower than in developed countries, and getting government ethical approval for each of these countries I expect would be a very onerous exercise.
The ongoing relationship issues between PP and EMS also certainly haven't helped the situation.
With regard to the recently announced contract manufacturer, I contacted SC after that ann. and was assured that there were already enough doses to complete the trials. The contract manufacturing agreement will be used for quality assurance purposes during the next step of product registration.
Anyway, I'm still holding on the off chance that the trials get completed (one day?), and this product can be made available in developing countries for humanitarian uses.
bluebush
EMS Price at posting:
1.4¢ Sentiment: Hold Disclosure: Held
