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Re: rcstock post# 81391

Tuesday, 02/27/2018 3:27:41 PM

Tuesday, February 27, 2018 3:27:41 PM

Post# of 144814
Thank you for sharing this info.

Also, because such studies are being done by other companies for us, we cannot control the way such studies are done and the timing of them because they may be involved with studies for other companies as well.



KW is a lawyer, right? This is a simple vendor contract with delivery due dates and associated penalties for delays. It is very normal when doing business with other companies to have contractual obligations; it is not normal to hope they can get to your stuff.

You may remember that in 2017 we lost essentially 6 months from our timeline simply because we could not obtain the proper growth medium for the cells that we use for the population of our Master Cell Bank and then used for encapsulation because the single supplier in the world (a major company) was unable to produce it according to specifications



Incompetence/poor planning. Simple due diligence, and one item up front on your project plan...long before it can cause an impact. Of course, if there was no project plan...then yes, everything is reactive and waiting for things to go wrong without anticipation or mitigation steps in place.

As for the involvement of TD2 – no, they will not be involved in conducting the trial. This was essentially their decision because they did not believe that they had enough infrastructure to coordinate the conduct of a trial like the one we will be doing. TD2 is more suited to coordinating the conduct of Phase 1 and early Phase 2 trials.



Then why were they signed and announced as our CRO when it WAS a Phase2b trial we were going to run? I'm to believe they could handle 2b trials at that time, but now, they can't? I see...let me go drink some more kool-aid to properly get on board again.

I've been a supporter for a long time, but enough of the BS.

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