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railroadman

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railroadman

Re: Lc3ltd post# 11853

Wednesday, 12/13/2017 9:44:34 AM

Wednesday, December 13, 2017 9:44:34 AM

Post# of 12450
Another delay. The unknown is the FDA response a Refusal to file letter or a CRL??

Interesting reading when you google Refusal to File Letter.

Unknown how long this will take to correct. It is the second delay with the FRA.

It raises question about other NDA's in the pipeline. Potential partners will be all over this with the company.

Rizaport still needs a US partner. Waiting on the Tadalafil announcement.

Plant approval by Health Canada still in the Q.
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