Pluristem Therapeutics Inc (PSTI)

[skitahoe]

Let's discuss PLX-R18 briefly. Initially I believed that this should be tried in pneumonia, it wasn't the direction the company choose. What are peoples thoughts about whether it will, or has already been tried, or will in the near future.

I cannot say why the company did as they did, other than perhaps the belief that PLX-PAD was closer to approval. I frankly believe the U.S. Govt. based on animal trials for radiation could declare PLX-R18 approved, essentially as a cover my ass way to make it available for use off label immediately. I don't know that PSTI has filed for such approval, but when it comes to CMA solutions to problems, perhaps that could be ignored at this time.

We know the drug is being used in human trials for other things, but none are close to approval, agencies like the FDA want coverage for saying they're okay with using a product off label. An approval for use in radiation, based on purely animal trials would provide them such coverage.

Gary