Pluristem Therapeutics Inc (PSTI)

[skitahoe]

Jimmy,

One of the problems with our drug approval process is that no matter how good the Phase 3 data looks, between the company having to prepare a BLA or NDA that's very complex, and the FDA taking 6 months to evaluate it, the better part of a year or more is spent in the process. If the FDA wished, they could do otherwise, look at the data themselves, cut the red tape and approve the drug. That would make it available immediately for off label use in pneumonia.

I'm not a believer that this will happen, but if a substantial number of people are tried in pneumonia, perhaps they'd act to do something there, whether it's called an approval or not.

I believe that if the benefits are so clear that no one can deny that people who get our drug have a much greater chance of survival, I've got to believe it will be Internationally accepted, and while the U.S. FDA may not be the first, they will come around. I think that either Israel or Germany may be first to accept the drug, as they're first to be testing it. We've not yet heard how far the German effort has gone. I'm hoping they've dosed many more people, but until something is announced it's purely speculation.

It would be nice to hear more from Israel, especially if we were to learn all 7 who were initially dosed have improved to the point they're being released from the hospital. 7 is a small start, but all 7 were on ventilators, many advanced to the point of going on ventilators don't make it, but 7 isn't sufficient to move the FDA. I really believe that they have adequate drug available and would hope they get the drug to somewhere between 100 and 1000, that could produce undenyable results.

Gary