I think the reasons given by Jon for halting the PW trial are genuine, but doing so does have a commercial advantage in my belief. He followed up those comments by saying if they can establish a new protocol for conducting future trials without onerous safety oversight because the safety of the drug has been proven, it should make future trials more streamlined and less onerous to conduct which is clearly beneficial for the asset holder and the patients. Theoretically, a new trial safety protocol might make it quicker to launch several Phase 2 trials on the back of a takeover in addition to moving forward the 3 current indications into Phase 3.
Initially I wasn't sure if I agreed with this move, it seemed out of sync with industry practise meaning I would consider it rare to halt a trial because you think you can get perceived onerous conditions for conducting the trial removed. Any other small pharma would have a heart attack if it meant delays to potential commercialisation and more money spent on development and trialling especially part way through a trial, I mean there is no issue with the trial itself regarding safety. Delays can occur, frustration with patients and their families ensue, but then again I don't know the plight of the patients and their families when it comes to participating in trials and how it can upend their lives in the interim.
After some consideration I think its a positive move for everyone involved and of course I trust Jon's judgment, he is a man of integrity and he hasn't let us down thus far.
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Ann: Phase 2 trial shows significant improvements in Pitt Hopkins, page-148
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