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SENASTE
Redeye endorses the outcome of IRLAB’s end of phase II meeting with the FDA, including the recently communicated protocol (written minutes), which was positive in our view and in line with expectations based on previous communication. From the written minutes, we learn that the FDA and IRLAB are aligned on important matters such as choice of primary endpoint (UDysRS part 1+3+4), patient population and required safety documentation. IRLAB states that the estimated sample size for phase III will be 200-250 patients, which we consider to be beneficial and gives the company some additional flexibility. We will return with a more thorough comment next week.
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