The more I consider the PR, the more concerned I get. How is it that the protocol for the combo trial could not have already been determined? If it was already determined, as one would reasonably expect, why would the company be looking to change it at this point? The only sensible conclusion is something negative is going on. If the data was good after reaching the 30 patient mark, the company would have run with it and raised the needed funds on the back of it. While they don't know the exact data yet, you can be sure they know something about it that must have raised concern about the ability to raise money of it.
I really don't see how there is any other reasonable conclusion that can be reached. Investors should prepare themselves for bad news.
Now, if there is enough there to give the FDA hope for the future of the drug, they may be willing to make the company's requested changes since the FDA would likely be aware that the company may not survive if they are unable to raise money soon. That may be the best hope right now. But the company likely needs money right now and it is hard to see how they raise the needed funds anytime soon if they have to find more patients and have to revise the data analysis. New money would have to be skeptical and the discount to the current price would likely be severe.
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