Pluristem Therapeutics Inc (PSTI): Hello Straightshot, I had many questions...

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HappyBee

Re: Straightshot post# 9651

Thursday, 01/18/2018 11:59:12 AM

Thursday, January 18, 2018 11:59:12 AM

Hello Straightshot, I had many questions regarding clinical trials myself. This is a highly specialized field and I would hesitate to give you an opinion on your specific questions. I am posting two links that hopefully clarify certain issues. I found the information very helpful.

Regarding the first link (I recommend to read the whole document), page 9 discusses endpoints and page 14 clinical trials in more detail. On that page there is reference to a Data Safety Monitoring Committee. The second link (from the EMA) will explain that further. I hope this helps. Apologies for not being more specific, but I want to avoid at all cost writing something that could be seen as misleading. Best wishes, HB

http://www.esourceresearch.org/eSourceBook/ClinicalTrials/1LearningObjectives/tabid/192/Default.aspx

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf