IGXT - Basically drug is OKEY DOKEY. Recap. IGXT partners..current partners include DAVA Pharmaceuticals, Inc, Edgemont Pharmaceuticals, LLC, Par Pharmaceutical, Inc, and RedHill Biopharma Ltd.
IGXT is expected to bring other products into the market with commercialisation agreements in the near future.
Regarding CRL: The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm(TM) product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.<---This here is EXCELLENT because safety is a big concern.
Here's the KEY why I like to continue watching IGXT:
FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; IntelGenx and RedHill plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks based on available data.
I would watch both PPS movement & news from both IntelGenx and RedHill Biopharma
IGXT "I felt that people may get tired of waiting and move on.". Absolutely agree. The good thing is...for some folks $0.80-.80s can be a support and wait out for next update. It seems to like hanging around $0.80-ish here. (Easily one can whip a 30% profit at this current level IMO)
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