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1. Complete P3 data so far get reported in Feb/March time frame.
2a. Results are fantastic and thus, company goes to prepare for NDA in the fall
2b. Additional fund are raised with PPS popping around 20 in preparation for NDA and continuing trials
3. Continue trials to add to current data to NDA submission in the fall
4. Drug gets PFUDA date some time in the middle of 2023 for approval...
5. Drug gets approved.
Fly in the ointment for shorts is that when new capital is raised PPS would have jumped significantly from current levels so covering with new issued shares would not be profitable. Big loss and a Big gamble in shorting here with all the good data so far on the drug!
GLTA in stock casino!
Here is an excerpt from company PR:
The ongoing ACTION-Galactosemia Kids Phase 3 study is evaluating the impact of AT-007 treatment vs. placebo on clinical outcomes over time, including cognition, speech, behavior and motor skills. Clinical outcomes are assessed every 6 months by a firewalled committee. The first assessment will be completed in the first quarter of 2022, and then every 6 months thereafter until the study reaches statistical significance.
First assessment will be 1Q2022. Probably some time in March. If past data are any indication then it should be good results. Just have to wait and see and then every 6 months....
Only have to wait about 2 months for first inkling on P3 data...
GLTA in stock casino!