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flipper44

03/05/17 11:45 AM

#105997 RE: AVII77 #105993

What do you think about the NICE incentive that seemingly places companies in the strange position to leave their OS blinded longer in order to get more monetary valuation on their product? How would they make a fair determination when a crossover is in play? What historical precedence, concurrent or post approval results, if any, could they instead use in order to get these products to market instead of potentially forcing companies to pad results. Can market price be increased if commercial data demonstrates additional longevity? Finally, why does a company like AZN, in their most important MYSTIC trial, believe they can unveil PFS ahead of OS. Other than market confidence, what advantage does it bring them?
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Doc logic

03/05/17 11:19 PM

#106027 RE: AVII77 #105993

AVII77,

We are coming from different perspectives. I believe your perspective is based on past trial problems with pseudoprogression and an emphasis on the potential limitations from criteria that are being used to determine a progression event in this trial even though pseudos are being removed. When I ask where the missing pseudos from what would be expected to be a higher total from all arms including from the pseudo trial, informational arm and compassionate use, you would say they are in the main arm of the trial and being counted as early eventers which would perhaps place the first red dot in your graph where you have it right? Based on that rational, your perspective makes sense.

Now consider something different. There would have been a significant number of pseudoprogressors found between the end of 2014 and October 2015. Where are they? The pseudoprogessor arm stopped enrolling at 32 and this happened well before the hold was announced. Did they really not find enough pseudoprogressors? That does not compute. What does make sense is that a comparison was made between treatment arm and SOC in that trial and there was a very dramatic positive difference. Now how would that affect the main arm trial? If what you have said indeed bears any weight then you might need to find out who is being enrolled in the main arm that should not be receiving SOC but instead moved straight to treatment. Radio silence even if the stock crashes right? Best wishes.