RE:RE:RE:Mackinnon80, what's your educated take on that one ?Great post Bepando and good point. They might go directly to a pivotal study or that kind of phase 3 study. I said phase 2 only because that would be part of a standard clinical program.
That beind said I don't think the current phase 2 data for the type-1 plasminogen deficiency could be used to extrapolate the preliminary efficacity (usually part of a phase 2) of injecting plasminogen directly at the wound site of diabetic patients. But you're right I can certainly see a FDA approval after only one study.
To FD : at this point it would be hard to extrapolate the dosage or the # of dose (of plasminogen for chronic diabetic wounds) PLI could get per 100 000 liters of plasma. Shen (Dr Ny' post graduate student at the time) doesn't specify how much uM (microMole) of plasminogen there is in one injection dose he gave to each mice, nor how many injections it took to heal wounds in db/db mice. Would be an interesting question for friday' conference call.
M80