Press release statements should be read very carefully and it is always difficult to overcome your own biases when interpreting the words. But those words have been very carefully chosen and the lawyers have gone over them with a fine tooth comb. What is in the PR and what is not in it are important.
In this case, the release indicates the combo trial has not yet closed pending a discussion with the FDA, even though they have already met the required 30 patients. In the Ibalizumab trial, they went to 40 patients even though only 30 were required because some of the patients were so sick upon entering the trial that they died (4 of them). So, a similar thing could have happened here and that is why they are going to be discussing the trial size with the FDA before closing it. The reason for the delayed closing could also be something else that is off the radar screen. The statistics are pretty important and 33 patients leaves a lot of wiggle room for weird results, hus companies facing a binary event like this generally like to recruit more patients rather than have some statistical oddity crush them.
Obviously, a delayed closing to the combo trial means a delayed application for approval to the FDA if the data does look good as we expect. They say hey are going to file the BLA in the first half of 2018. My experience in these things suggest you should assume June 2018. Which likely means approval in late 1Q19 or early 2Q19 at the earliest. But you should also factor in some delays as there always seems to be some.
It was encouraging to see the company reiterate their own optimism based on previous results. One hopes they are trying to communicate that they are actually optimistic based on the limited look they have into the current trial.
On the brief mention of the mono trial, it is noteworthy that they did not mention anything about meeting the 300 total by the end of the year. I would say that signals they don't think they are going to make that and I would not be surprised if the current cash crunch is limiting their ability to grow that number as fast as they would like.
So, the bottom line from my perspective is the timelines have been pushed out across the board (which is what always seems to happen with drug trials) and there is a new element of doubt about why the company wants to talk with the FDA before closing the combo trial.
Also, it is another reminder that when a small drug company is overdue for giving you an update, it rarely means there is something good going on.
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