I was surprised to see some concerns about the marginal statistical significance of the PFS result in the Phase II, because that result was very strong, despite the small sample size. What worried me, however, was that PFS was a secondary endpoint, and people seemed to be ignoring the primary endpoint (decreased toxicity).
While the overall toxicity rates were not different between the two groups in the Phase II, the rate of diarrhea was actually 20% in the treatment group and 9% in the controls (p=0.20). While this looked to be possibly due to accidental imbalance at randomisation, or possibly some artifact like increased duration at risk through higher numbers of treatment cycles, it was possible that this was a real problem, and that HA somehow ALSO targets cells other than cancer cells, which result in higher rates of diarrhea. The fact that the DSMB did not stop the trial has therefore addressed my number one concern.
Now its all down to everyone's own estimates of risk and reward. Having previously blown my money at the last hurdle, I can't fault others who choose to pocket their profits, especially as there appear to be some with huge exposures to this stock. Good luck all!!
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NEURIZON THERAPEUTICS LIMITED
Dr Michael Thurn, CEO & MD
Dr Michael Thurn
CEO & MD
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