MD&A and Financials are posted
posted on
Jul 30, 2018 11:24PM
A few significant timeline observations in the MD&A posted tonight. Overall, seems like timelines in the MD&A are being revised to a slightly later date than previously discussed. But how much of this delay is due to $$$, and how do these delays effect the possibility of Nasdaq listing soon? In the grand scheme of things, these are very small delays.
1) xB3-001 pre-IND meeting. "The Company previously anticipated being in a position to schedule an FDA Type B (pre-IND) meeting in Q3 of 2018. We have determined that additional time will be required to prepare for this important meeting and, as a result, have revised the target date for the FDA meeting to 1H 2019." Hopefully this revision to the pre-IND meeting schedule won't affect the timing of the toxicology program and Phase 1/2 human trial.
2) xB3-002 pre-clinical work. The MD&A states "Initiation of pre-clinical studies are targeted for 1H 2019" but the recent Corporate Update Presentation showed these staring in H2 2018.
3) xB3-007. The MD&A doesn't give much detail on this program, but the recent Corporate Update Presentation disclosed that this neurodegeneration program was for glucocerebrosidase enzyme replacement in Gaucher's disease and that these pre-clinical studies would start in H2 2018.