BTD usually are given much earlier in the drug testing process. Has any other drug been given BTD after its first phase III was nearly completed?
I think you are also forgetting that the current phase III trial will not actually be completed until February 2018, then you need time to put the application together. Early 2019 is the best hope for approval but investors should be aware there are almost always delays in the FDA approval process.
Also, how can the company be actively raising $15 million in new money without a filing about it? Is it covered by some other previous shelf filing? Shouldn't we at least have a press release on that. And if they couldn't raise $15 million with a more attractive convertible offering, how are they going to raise it with a less attractive stock/warrant offering?
I think having Tony at the helm right now is absolutely critical to the company navigating the significant hurdles the company still faces but there has to be some way to translate good test results into a marketable product. It is going to be interesting to see how this all works out, but it will likely work out. The only question is the dilution required to get to there.
Remember, there likely are not a lot of revenues associated with combo commercialization and mono is still a ways off., especially of a large second phase III is required by the FDA as I would expect. Has the company ever explained how they see the market for combo in any of their presentations? If so, can you point me to that?
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