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Re: 2012 Insight RRP is life threatening in some percentage of cases and the trial is in a dose expansion Phase NOT dose escalation. They will NOT be switching to a higher dose although they may later add re-dosing if needed. We should never allow regulatory barriers get in the way of solid, fact based decisions. "Efficacy based on prior surgeries is good, but a somewhat flawed barometer because it is scheduled." I am not sure what you mean by scheduled. Most call their doctors to tell them they need a surgery to bring back their voice and one is scheduled. The same patient/doctor input is used post treatment as pre-treatment. Path forward IMO is PGEN and FDA will agree on a pivotal trial that ... - Establishes a pre-defined approval level of surgery reduction that they will likely meet. The pivatol trial already has 32 enrollees. The only question is how many are required and to all have to complete the 12 month followup. - Bunch of sites; because why not They will not. Why - Possibly randomized between DL2 and DL3; safety data too good to rush DL2 to approval NO!!!!! DL2 is the level - Is there a way for this be Rare Pediatric Disease voucher eligible Not sure. I do believe they will be entitled to a voucher for another drug. |
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