Friday, May 30, 2014 8:50:22 AM
BTD is something special, that most drugs dont get anyway.. its not an all or none, its just a short cut to being approved.
PV-10 didnt get BTD because they didnt have enough data, FDA agrees that the drug works, but more data was needed for the special BTD designation
bridging study to get the data to resubmit for BTD or a Phase III will be needed. yes its more time, more $ but the drug works
people need to do their DD and know what kind of time frame were looking at
I hope the mgt learns a hard lesson from this and moves quickly on the other trials (PH-10 etc).
my .02
smalls
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