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bbhuey

12/05/17 8:42 PM

#11854 RE: Lc3ltd #11853

I think this is a good thing for igxt
Rdhl did not want to spend money on the new batches to respond to the last cei.
Igxt had to create the batches themselves before they would agree to pay the costs which delayed things for over a year while other competitors have appeared.
Now that they have control ,their own plant and better pharma partners with stronger channels of distribution.rdhl
was treating this as a distraction and busy
with their other drug trials that they consider bigger fish to fry.iif there is enough of a market igxt has an advantage as now they are the mdg.inly thing is they did not announce what the deficiencies were .maybe rdhl this time had the deficiencies time will tell.
I am waiting for them to partner tadafil.
I got some more at $.65

railroadman

12/13/17 9:44 AM

#11859 RE: Lc3ltd #11853

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.