Pluristem Therapeutics Inc (PSTI)

[n3m3sis]

For a recap of what it means if this bill is signed...

"Traditional pathways to [FDA] approval and licensure of critical medical products, like freeze dried plasma, for battlefield use are too slow to allow for rapid insertion and use of these products on the battlefield," a Senate Armed Services Committee's conference report indicated, as reported by Politico. Freeze dried plasma has been the prime example and a reason for the proposed law in defense circles. If passed, the law would apply to any medical product, including cell therapies. The Pentagon appears to be taking things into their own hands.

Clearly, the Department of Defense is interested in Pluristem's PLX-R18 because it is already conducting studies for the cell therapy in ARS. PLX-R18 works by boosting blood cell production in bone marrow. High doses of radiation can destroy the bone marrow's ability to produce blood cells, leading to a risk of death.

As an off-the-shelf product, PLX-R18 is ideally suited for rapid deployment in large populations in case of a nuclear emergency because it can be administered without prior testing of individuals for their level of radiation exposure.

A pivotal study for FDA approval in ARS under the Animal Rule and potential orders for government stockpiles were considered the next step for PLX-R18 in ARS. However, if the National Defense Authorization Act passes with Section 732 intact, then the Department of Defense could speed up PLX-R18's approval. Pluristem and each of its cell therapy products and indications, including those in Phase III, would benefit.

U.S. Senate's National Defense Authorization Act Gives Pentagon the Power to Immediately Approve Pluristem's ARS Antidote

The language was passed unchanged through both Reps and Senate.