The thing that is the biggest risk for sure is the animal study in my view.
the 505(b)(2) pathway approval suggests that a change in delivery method (now nasally applied), may need safety / tox studies regardless.
If the company waits till Q1 next year with their pre-IND meeting with the FDA, then they get told the FDA wants several months of animal study first, this is going to preclude the NDA submission so tox study gets done, results posted, then another IND meeting with the FDA.
I just dont see how, a meeting with the FDA in Q1 next year for an IND application can facilitate an approved drug in the same year when the new drug application takes months to prepare and file and this takes almost a year to review. Then chuck on top of this an animal study. You can see my concern in the timeline.
I don't know how much data the Australian data can help in mitigating a very drawn out American process. My hopes are high, but as I have experienced with ILA, I am not holding my breath for an entirely expedited approval from the FDA.
LTP Price at posting:
98.0¢ Sentiment: Buy Disclosure: Held
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