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Re: flipper44 post# 151544

Monday, 01/01/2018 8:28:30 PM

Monday, January 01, 2018 8:28:30 PM

Post# of 699764
I agree Flipper! Thank you! And if you look very closely to the 2016-10K p.5 you can see the Compagny stated the same additional piece of information about closing enrollment when they are talking about lifting the hold by the FDA and also when they are talking about the self- imposed hold on screening in countries outside the US. It is my believe lifting the hold has nothing to do with closing the enrollment And by mention it twice that they are not going to enroll the last 17 of the planned 348 patients it is my opinion that the Company wants to make it clear that closing enrollment has nothing to do with lifting the hold!

Quote:
________________________________________
The trial was on partial clinical hold for screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016.

2016 10K - page 5
https://www.sec.gov/Archives/edgar/data/1072379/000114420417020754/v464066_10k.htm
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