Flipper, you make some valid points about the Direct phase II trial enrolling quickly. But if a phase III is required for Direct, I believe there's no way that Direct could be approved before DCVax-L. Phase III trials take time.
The Direct trial lists its primary endpoint as "Number of patients with adverse events" which is PFS. So if the vaccine works, they won't have instantaneous data for the FDA.
I'm not discouraged by this. At least not as an investor. If the data is good, the stock price will respond long before FDA approval.
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