Where there’s smoke there’s fire. Mav has suspected the same issue with regards to waiting for the results from the combo trial(s). And your thoughts on the concerns that RAs might request a confirmatory trial offers a possible explanation. This may also explain why a joint venture agreement hasn’t been signed yet, since the BP partners may be waiting on the same results before moving forward.
The problem with this line of thinking is confirmatory trials are decided in advance. And i'm not sure they can apply this combo to their current mono approval. But we will see. They are to the point where they aren't funded to run a trial on their own.
But i agree 3 plus years is ridiculous amount of time to submit to anyone who knows this game.
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