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Re: rcstock post# 51921

Thursday, 08/25/2016 8:49:54 AM

Thursday, August 25, 2016 8:49:54 AM

Post# of 144812
That's right and wrong. It took the Thai Government and the other agencies 17 months to approve Austrianova's facility. It was not approved until, April 25, 2016. Since that time the trials have been scheduled to start in December, 2016. I know there were mentions of a 2015 trial but there was never a month mentioned in the past and it could never happen until cGMP was granted. They really have not missed a date on trials. cGMP's decision was always something they had to wait for. Other than that I think you will feel better about the forward progress if you take a look at the timeline in the sticky's.

KW has been at it for about 32 months and 17 of them were spent waiting for the most important step before they could even think about setting a trial date. Now, PMCB has to wait for another government agency to set an IND meeting. So, they can hope December but if the FDA sets the preIND meeting up for January, 2017, then they obviously will not have trials in 2016. Would that be KW's fault? Of course not. Will it be said it is? Of course. That's like stealing candy from a baby. East and takes no talent.

So, hopefully the FDA stays on track at this point and we keep our start date in 2016.

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