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Re: loanranger post# 259740

Friday, 04/05/2019 12:56:37 PM

Friday, April 05, 2019 12:56:37 PM

Post# of 403047
LR, it is my understanding that the 'confidentiality' is usually due to details which sponsor regards commercially confidential (issues relating to manufacturing process for the drug in question, for instance) not so much what FDA wants to keep non-public.

What I really wanted to do was to instigate somebody to search complete transcripts of EOP2 meetings made public in order to show how silly I am. I haven't found single one. But my effort backfired as usual, the crowd here is minimal work crowd; you and few others excluded.

BTW: we do know these items either from press releases or by inference:
1. Agreed P3 trial population: subjects having head and neck cancer undergoing IM RT with cisplatin Q1W or Q3W chemo.
2. Endpoints: SOM incidence, time to emergence of SOM, Duration of SOM

What has not been spelled out are precifics on trial size and safety, but those things seldom are included in press releases about EOP2 meeting.

I would like people asking for transcript (which IPIX did not promise to deliver to us) to name what additional things we might reasonable learn from EOP2 transcript made public by IPIX. Potential partner present in the meeting would surely be redacted among other tidbits.

"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman

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