To some degree I also have some reservations about this announcement and was not able to get a definitive answer from the Presentation.
My one and only question regarding this announcement relates to how this new trial design will impact our ability to get approval.
Notably they have cut down number of patients from 114 to 45 and the time from 12months to 6months of dosing. From the announcement it seems that this would need to complete a Phase 3 study. The key however lie in the second paragraph:
"It is the Company’s view that if results from the Phase IIb proved to be highly successful, it would thenengage with Regulatory Agencies in relation to obtaining an accelerated approval for the unmet medical need of non-ambulant DMD patients."
It seems that if all goes well, then we may be able to get through via accelerated approval whilst doing a Phase III.
On the other end of the spectrum, the worst case scenario is that we would not get the accelerated approval and may need to do another trial. (If it doesnt work, we got nothing anyway)
Pros:
- Accelerated Approval Possibility
- Faster confirmation that the drug works
- If the drug does not work, less capital was used and less dilution
- Cheaper Phase III trials due to lower number of arms dosed (unsure if this is a pro if we have to do another trial pre-approval)
Cons:
- Non-definite pathway towards approval
- Potentially further delaying the inevitable if not granted accelerated approval.
I'd say that a lot is banking on this next trial being robust, and the margin of error has increased. Hard to see the Share Options converting unless there was accelerated approval.
Definitely a high risk high reward play here instead of a straight up raise at these prices. The high risk is time potentially lost.
Perhaps after this trial, there will be more appetite for a raise at a price that is hopefully higher than 10c. Agreed though, financing has been solved with slightly higher odds. Unsure how I feel about this.
