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Re: thinkingonlygreen post# 22173

Wednesday, 06/12/2019 10:25:56 AM

Wednesday, June 12, 2019 10:25:56 AM

Post# of 43787
@Thinkgreen

NO CHANCE we are ramping up production. NONE

FDA Approval is probably well over a year away. I bet that they, ("Cel-Sci"), want to get ahead of certain processes and milestones, but production... NO

My best guess is this:
~They believe the trial and data will be successful

~ We are anywhere from 2-5 months out from any data read out. Yes...you read that correctly.

~ If/when the data is deemed successful, they will need to start filing a TON, and I mean a TON, of documents, forms, etc for approval and show the FDA they are ready to market/sell MK.

~ Interviewing, hiring and onboarding/training 4 new employees will take at least 2-3 months. There is always a learning curve when joining a new company which is why i say 2-3 months inclusive of onboarding/training.

~ This 2-3 month time frame is inline with the next IDMC meeting in August. This will be the FINAL IDMC meeting in my opinion. News from this meeting will be 1 of 3 things 1) Continue to end point reached 2) end study for futility or 4) End study for ethical reasons as MK is working.

@Woolrich, what you say on my post?
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