It will be interesting to see if PAR have to pay a Type I penalty for having a peek at the primary endpoint for 002 part 1. Ordinarily they would need to pay a Type I penalty, but this is made more complicated by the fact they expect to use a new dosage. PAR should look to get clarification from the FDA prior to initiating stage 2 to prevent any surprises otherwise they may fail to achieve statistical significance even using the higher dose.
It will be interesting to see if PAR have to pay a Type I...
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