I totally disagree regarding your view of the Prurisol trial. Both Dr M and Leo spent time in Feb at Dr Reddy's, were impressed with the 30-40 scientists Dr Reddy's had put on the Prurisol project, and immediately upon return to the USA Pr'd that the team in India had found ways to streamline the mfg. process to greatly reduce cost. As a result, they said in that PR that a new batch of Prurisol had to be made for the trials using the new, streamlined manufacturing process, and that this new batch would not be available until late July. Then the clinic would have to schedule the Prurisol trial into their lab AFTER it had been approved for the trial by the FDA. We knew by early March that the trial was not going to begin in April as we expected prior to the trip to India by mgt and that the new Prurisol trial date would be Sept at the earliest and maybe into Oct-Nov before beginning because once the medicine is delivered it has to be approved by the FDA (30 days or so?) and then worked into the clinics schedule (maybe another 30 days?). We have known this for months, there was a great reason for the delay of the trial start date, and as such I see no reason to believe Prurisol is not primed and ready to go as soon as all the loose ends are tied up once the new medicine is delivered in late July. For new readers, you cannot run a trial using medicine manufactured by one method and then change the method of manufacturing after the trial as there would be no effective way to know the new method medicine would work the same way as the old method medicine and have the same shelf life, strength, etc.
In my view Prurisol is as primed for for trial and as assured of success now as it was in Feb when we thought the trial would begin in April. Sometimes delays happen with no sinister reasons behind them and this is the case with Prurisol as I see it.
I agree completely with your Kevetrin opinion.
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