Lisata Therapeutics Inc (LSTA)

[Viperciara]

Here is a good article>> http://www.thelifesciencesreport.com/pub/na/why-investors-shouldnt-worry-about-explosive-new-drug-pricing-maxims-jason-kolbert

Here is the part I like!>>
JK: I feel like I've already seen proof of concept in Mesoblast's product, Athersys' product and NeoStem's product, NBS10 (autologous, bone marrow-derived, CD34+ /CXCR4+ enriched cells). By default, I expect the Pluristem product, PLX-PAD (full-term placenta-derived adherent stromal cells), to work. PLX-PAD is a heterogeneous mixture of cells, which differs from Mesoblast's mesenchymal precursor cells and Athersys' MultiStem, which are both homogeneous groups of cells. The company's lead indications are peripheral artery disease and muscle injury, including that associated with surgery for total hip replacement.

TLSR: You've mentioned NeoStem a couple of times. Last November the company reported top-line results in its Phase 2b PreSERVE-AMI trial of NBS10 in ST segment elevation myocardial infarction (STEMI). It did not meet its primary endpoint of cardiac perfusion. Yet you see proof of concept. What do you mean?

JK: The STEMI trial showed a tremendous mortality benefit and an improvement in virtually every secondary measure. That improvement, by the way, was recently affirmed at the American College of Cardiology, when Dr. Arshed Quyyumi, the principal investigator, presented the 12-month follow-up data. What I see in the NeoStem PreSERVE-AMI trial is a very successful study. The bears will say one of its primary endpoints, perfusion, didn't show a sufficiently low p-value. But perfusion is not an approvable endpoint in a pivotal trial anyway. Mortality is, and NeoStem has shown a mortality benefit.

If a stock is cut in half on bad Phase 2 data, whether NeoStem or Athersys, I would absolutely be buying more, because I don't believe the Phase 2 endpoints are significant in either trial. The Phase 2 data that NeoStem reported were good data. What investors have to understand is that sometimes Phase 2 data won't give a low enough p-value, but does give information on what a company needs to be successful in Phase 3. If, on the other hand, the Athersys or NeoStem data show no trends, and no difference whatsoever between placebo and the active arm, that would be very disappointing and would suggest something is not right