Tuesday, October 22, 2019 12:48:14 AM
We know there was a planned submission to BARDA this September regarding R18, whether that results in a small purchase and/or confirmation of payment for the Pivotal NHP trial will have to be seen.
We know there will be Europe CLI Adaptive Pathway potential approval data in April/May 2020 as the sample for this was already enrolled this April.
We do not know how far they are along with Hip-Fracture study, but that due for July 2020 as per PSTI's guidance, which you can choose to ignore if you like. If July 2020 is going to be a viable end date then we would hope to hear last patient enrolled about 6 months prior (as the endpoint is 26 weeks later), so about Jan 2020. They have confirmed 19 centres recruiting 240 samples and only time will tell of recruitment is on-track or not. This represents an average of 12-13 patients per centre. The study started July 2018 so hopefully being 15 months in, that we should have a good amount of sample enrolled. Especially as there is no major key drug treatment for Hip-Fracture muscle growth and that there have been zero safety concerns in any human administered PLX cells.
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