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Re: jpaz70 post# 6168

Saturday, 07/19/2014 10:23:43 PM

Saturday, July 19, 2014 10:23:43 PM

Post# of 9931
No no no
That's not what I meant but I can see how you took that wrong
Sorry for not being more clear

I meant that if the data management committee, who will be monitoring the pIII trial does what they are suppose to do, i.e. A rolling data analysis... Shows that Pv-10 is superior after 4-6 months.... Around 50 patients...they will recommend the study to be shut down and that the comparator group be switched to Pv-10

I am assuming that Pv-10 will show superiority

If that is the case then the difference in the time line would be about the same
And only about 3-4mm will have been spent

I posted links to the FDA sites on the rules on that

I did not mean to suggest a short bridging study equals a full blown pIII

The pIII are run until a significant difference is shown then enrollment is shut down per FDA

Full pIII is run when the data is so so

Read the links to the FDA I posted which explains that
I will not, in good conscience, purposely mislead anybody
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