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gdollasign

07/29/14 6:25 PM

#180807 RE: masterlongevity #180804

It isnt possible that Harvey Berger is running 2 companies is it??
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jq1234

07/29/14 10:54 PM

#180814 RE: masterlongevity #180804

>> Other issues I have with SRPT is the snail's pace at which they have gone from phase 2 to phase 3 (in fact trying to avid).

GSK rushed Drisapersen to ph3 from ph2 with inappropriate inclusion criteria. Was that type of SPEED from ph2 to ph3 preferred over more deliberate pace to ensure appropriately designed registration trials? You can't simply copy precedences from other companies in these rare genetic disorders, like so many other indications. To ensure higher chance of success, they SHOULD go slow in deciding appropriate inclusion criteria and duration of trial etc. It took PTCT 3 years to design Ataluren ph3 trial after ph2b failure, it sure has higher chance of success than ph2b by taking their time, better than rushing from ph2a to ph2b resulting failure. Speed likely means failure in these types of rare indications!