Wednesday, July 29, 2015 3:40:17 PM
"They also intend to file for Orphan Designation and Fast Track Status in Q2. This was confirmed with their CEO.
According to the FDA, the response timeline for ODD is 90 days or less, making this a Q3 catalyst.
According to the FDA, their response timeline for Fast Track Designation is 60 days or less, making this a Q2/Q3 catalyst.
Initiation of 2, Phase II Clinical Trial for Triple Negative Breast Cancer/ Ovarian Cancer and Breast Cancer is scheduled Q3, 2015. All of their trials are investigator sponsored trials through the Mayo Clinic."
So the upcoming catalyst seem to be waiting for ODD and FTD (unless these already happened before my first buy-in mid June) along with the initiation of two P2 clinical trials.
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