Mark,
they are not on that list because they have as yet not made application. As just stated at the meeting with USFDA they (prr) were made aware they may be eligable for quick track approval under this scheme.Im not sure how it fits in with Phase 2/3 trials or if infact CVac can be commercialised before because there is a need and no existing treatment.
It may be that this treatment may become commercially available under this scheme to very late stage patients while early stages require further testing (phase 3 trials). This needs some clarification.
Mark, they are not on that list because they have as yet not...
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