Wednesday, August 02, 2017 3:01:23 PM
I think that the company will be able to ask/receive a significant portion of the value for mono within six months. They need 24 weeks of data from 100 mono patients to provide the safety data for combo, per FDA requirements related to reducing the number of patients for combo. Since the mono P3 is an open label trial, there is no issue with blinding the data, so real time results will be available to both the company and any prospective buyers who sign an appropriate NDA. If the FDA is receiving combo well, and the interim mono data at the time is strong (I think we have every reason to believe that both efficacy and safety will be solid), then mono will start to look derisked. Not completely, of course, as the FDA can do many illogical things. But if there are multiple potential suitors looking at it (as I assume there will be), then it begins a game of chicken over who is willing to pay the asking price earlier than the others. My guess is that management is assigning GvHD some value as well, and the "offer" will be "if you want to buy it for HIV, you're going to pay for it for GvHD as well." I think that the 24 weeks of mono data on 100 patients time frame is the inflection point where the risk becomes worth the reward for a buyout partner.
Completely my opinion, of course, but that's how I've always seen it. Interested in what anyone else thinks.
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