RE:RE:FD's projections - do they make sense? Let me go a little further here...
There are 3 sides to the risk analysis:
-1) Likelyhood it works at curing wound
-2) Likelyhood of side effects and bad tolerability
-3) Speed of the trials
I'd say the first is the most risky: what's going to be the rate of success at curing the wound. The small OMNIO sample hints at the fact that the rate will most likely be very high. Dififcult to measure without clinical trial. We'll see, thus...
The tolerability side is almost a given, from my point of view.
A) It's a human protein, your supposed to have it.
B) ProMetic process has a WW reputation at extreme purity and that's all that matter considering A). C) It's the same Pg than the one in trial right now in Pg-CPD trial, which boasts great tolerabilty and will have shown even more of it by the time phase II/III is done.
Now there's been an argument about the potential excessive concentration of Pg the treatment would result in. Here's my analysis:
About 2 litres of plasma worth of Pg will be used for Wound in one month, and 10-12 litres of plasma over a year for CPD. This means that the body Pk-decay about 1l of plasma worth of Pg per month. So the body would only have to support an excedent 1 litre of plasma worth of Pg.
The FDA allows people to give 625-750ml of plasma every week! That's a variation between 2.5 and 3 litres of plasma (and its equivalent dose of Pg) per month! So no, I don't think that a single excedent plasma litre-worth of Pg in the body per month will have any long term bad side effect. Especially since your *supposed* to have human Pg as human.
To top it off, the reason why we have to administer that Pg is that it doesn't naturally reach the wound due to (inflammation I think ?) so that administered Pg will be kind of trapped in the wound area due to the same (inflammation?) cause, where it will be consumed/decay at a high rate by the need of the curing wound, that actually needs to consume the micro dose of Pg to cure!
The third side is the speed of the clnical trials. We'll start directly at Phase II, the Pg being the same as in Pg-CPD. Because the amputation alternative is so dire, and the Pg will already be approved in an other indication, I guess that the recuitement will go very swiftly. We'll see when the protocol is out, but the trial itself will most likely take about one month per patient, like in most of the OMNIO cases. Well plus the regular 3 months of "observation" that follows the treatment per se. That could hardly last more than a year, right ? I can't wait to see if we're gonna be offered a pivotal phase II for that one too. I wouldn't be surprise considering the alternative.
My 2 cents
:-)
FD