Ann: Percheron launches post-trial access program, page-51

There is another aspect to the post trial access program that is not at all inconsequential. Its free. More precisely its free of charge so that the patients do not pay but somebody foots the bill and the bill presumably grows larger with each passing month. Remember back to the interview with the Board following the $13m institutional placement when the Chair said that we want to keep these boys on drug for as long as possible. Well, undoubtedly compassionate care isn't cheap.

Certainly its not an open ended commitment. The announcement refers to a period of time and so we get to the crux of the matter. If the period of time was to the end of a pivotal Phase 3 that may be an unsustainable cost for a small biotech. Say, however, that the interim results next month demonstrates not only positive signals but positive data that could form the basis for the grant of accelerated approval.

What would be the cost if the period of time was to accelerated approval? Maybe, the cost of the post trial access program is already included in the budget up to marketing authorisation based upon the grant of accelerated approval.

So maybe the heavily discounted placement was part of the cost in getting sufficient funds for an ambitious budget. Its all a series of maybe's but undoubtedly the Board's decision to keep the boys on drug will be greatly appreciated by the patients, families and caregivers who obviously have made the request via and at the recommendation of the trial investigators.