Wednesday, October 03, 2018 10:25:00 AM
and this is exactly the point! PLX-PAD cells were the same in Brueger's and Preeclampsia.
If we were talking small molecules in unrelated diseases with 'me too's', then her statement makes perfect sense.
HOWEVER...That's NOT what we have here.
A "Strategy" would have been to drive even 1 of these indications to approval to gather more safety & efficacy data to support 'Off-label' use until new trials could be done (funded) in new indications. The benefits in these others were already known back in 2003...
DO THE MATH over Time, $3-5Billion (at a minimum) left on the table by shelving these early ODD's. IT MAKES NO SENSE! - This is NOT brining shareholder value.
https://www.fiercebiotech.com/biotech/pluristem-s-plx-cells-receive-orphan-drug-status-for-treatment-of-buerger-s-disease
From 2011...
"Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically".
http://www.pluristem.com/wp-content/uploads/2016/05/Orphan_Drug_-_Preeclampsia_isa.pdf
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