PINL:GRPOF - Post by User
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Sweeetydion Feb 09, 2019 4:25am
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Post# 29341407
Health Canada
Health CanadaTo anyone of the belief that Tetra weren’t testing their drug lots for the entirety of the trial, you need to read HCs policy on CTs. Tetra wouldn’t have been given the green light to commence trials and continue if they weren’t. The tests weren’t positive for toxins until the test lot from 20 Dec 2018 returned.
The positive from this unfortunate situation is that no patients received contaminated drugs and that phase 3 is completed/ won’t need to be repeated.
Alright, so there’s a delay. We have an NDA application for 002 coming anyday. Perhaps that’s what TBP are anticipating. The NR from Thursday certainly gets across that having one DIN can really increase valuation, so 002 will be our first.