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Spideyboy

03/23/18 11:10 AM

#11376 RE: Scott999 #11370

I appreciate your points but I still wouldn't be concerned at this point.

Even if they have great results, it's very difficult for the majority of physicians to just take a company on it's word that it will be fine to use in another indication.

The vast majority of clinicians rely on approved treatment guidelines and clinical data to make their treatment decisions. There is ever growing scrutiny on following best practice and physicians run a high risk of losing their license if they can't defend themselves well in case something goes awry.

Clinical trials is the only get out of jail free card for physicians when it comes to doing something that isn't part of an approved guideline. While for products that have been around for decades, physicians will have more experience and anecdotal evidence to go off, label but for such new treatment technologies, you would be taking a very big risk in choosing a DFU approved product for CLI. These are pioneering times, care and caution and clear data is paramount.

Similarly, would you think that physicians would use PLX-PAD to treat DFU, if another product is approved for DFU? Even if the physicians wanted to, the FDA would require Pluristem to go do their own DFU study with PLX-PAD. At least starting from Phase II. Thus we can apply that logic to Celularity. Celularity can't just jump into or promote other indications without getting FDA approval.

Thus if there already is a product for CLI and IC, then the treatment guidelines will specific that course of action.

I think given their current course of action they are irrelevant to PSTI's indication. Again if they move and I mean directly move into our indications then that will be a problem.