Thursday, April 27, 2017 2:54:24 PM
I hear what you're saying, but I find it a little difficult to digest that the US government would have spent so much time and what must come to millions on performing the pivotal trial in animals, which is meant to get it through to market, and also why would Pluristem have it explicitly noted the following (quoted from the Pluristem Company Presentation - January 2017, available on their website):
PLX-R18: Expected Milestones
- Data readout dose selection studies ARS - H1/2017
- Contract with U.S. government for ARS – H2/2017
It would be unfathomable for PSTI or the US government to have taken the research this far, to then afterwards look at the safety data and then have it all fall apart. It would be nonsensical.
It would also be unfathomable for PSTI to have the above expected milestone statement of 'Contract with U.S. government for ARS – H2/2017' if it would suddenly be required to perform a newly needed safety trial within less than 6 months.
Also how could this be called a 'Pivotal' trial if afterwards another trial on safety were needed?
Your thoughts?
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