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Re: flipper44 post# 167572

Monday, 04/16/2018 8:58:47 AM

Monday, April 16, 2018 8:58:47 AM

Post# of 704648
Edited to meet TOS.

Basically, what [Fraunhofer] appears to be saying is that 300 enrollment was statistically sufficient for the trial. Perhaps for everyone. Remember what a big deal NWBO made about 300? Yet, the village people's digging into the last two or three patients enrolled, and statements by NWBO lead us to believe there were another 31 enrolled.

300 was necessary, sufficient and successfully manufactured for in America, Germany (and perhaps a few in the UK)? This then completed Fraunhoger's involvement. One will remember that it was Germany (PEI) that balked at the arm of 32 psPD. Might the manufacturing completion by Germany also signify their end to controlling that aspect of the trial?

This has been explored before, but not with the new information now available from Fraunhofer.

Anyway, 300 was reached by August 2015. Let's say August 5, 2015.

At the earliest, under those circumstances, if the last patient enrolled was still living, August 5, 2015 + 120 weeks = November 22, 2017 for end of dosing.

At the latest, under those circumstances, if the patient enrolled was still living, August 5, 2015 + 30 months =18. February 5, 2018 for end of dosing.

(At the very latest, if 331 actually completed enrollment by November 5, 2015 + 30 months = about May 5, 2018 for end of dosing.)

Why Fraunhofer did not discuss the apparent 31 still (at that time) to be enrolled somewhere else is a bit mystifying.

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