Pluristem Therapeutics Inc (PSTI)

[Straightshot]

The FDA knows the work we do witnessed by the recent Expanded Use designation... IMHO, the next logical step would be to successfully complete the steps necessary to file for the all important RMAT designation... this designation, again IMHO, would be critical if not necessary to get early approval for the ARS product... secondly, any meetings with the FDA would be with senior staff and reviewers... the FDA would provide us with a detailed roadmap which would include the type of information and data that would be necessary in order to accept any filing for review... while involved in this rolling type accelerated process, I'm sure mgmt will be made aware of the importance of accurate and reasonable timelines and will be held accountable... the first cell based approval would not only be rewarding for PSTI, its shareholders and patients but also a serious ego booster for Scott Gottlieb and the FDA in approving the first Regenerative Medicine Therapy in the world...