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Gabriel_S

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Gabriel_S

Re: None

Friday, 04/05/2019 3:38:54 PM

Friday, April 05, 2019 3:38:54 PM

Post# of 1738
Yes I saw that as soon as the 8-K filing was released. It's just a slightly longer version of it.

Item 8.01
The Company believes that the issues raised by the CRL, which were related to the concerns over reproducible dose delivery, can be addressed, and expects to meet and work with FDA to gain a full understanding of the Agency’s requirements for approval.



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