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uvaphd

03/05/19 10:20 AM

#77275 RE: hann-d #77271

Makes TOTAL sense. Need to compare efficacy for two meaningfully different processes. Having said that, what does the publication look like (in terms of time and scope)? Are they engaging in a second phase of trials using the new procedure? What constitutes a “trial”? If they conduct the new one using the same sort of timeline as with the first, then would we not be looking at roughly a year from whenever that second iteration began?

Several different ways to approach this, but I think managing expectations is important. Based on the only explicit communication to date, folks are naturally awaiting word on the results of the trial that ended on 8.28.2018. Moreover, at least TWO questions are worth addressing—and they do not necessarily need to be addressed at the same time: (1) what is the documented data for the efficacy of ANY CaverStem procedure? (2) how does CaverStem 2.0’s efficacy compare to the method used in the recently ended trial?

To the extent that the original centrifuge method was effective (to around 90%, as has been informally advertised by several principals for roughly a year) and the new 2.0 version is preliminarily as effective (if not more), would you not want to establish on the record the effective results that you CAN demonstrate—with the proviso that 2.0 is yielding similar effectiveness at lower costs to the performing physicians?

Even if they don’t publish the results of the original trial (for whatever reasons they deem necessary), they SHOULD issue SOME communication about that trial—especially if, as may be the case, they are now engaged in a second and fairly time-consuming set of variant trials. Managing expectations is ALWAYS key...