Thanks. I've been mulling what you had written prior. The more I think about it the deeper the ramifications become. I think I was mostly interpreting it as time delays at first, which seemed benign.
There will be a closing of some opportunities as certain percentages of people are cured. This will not be a disease like HIV; the number of infected people are finite, and the ones that will generate the most money, particularly so (USA/Canada/EU/Japan).
As you say, the bar will be high, the cost of the comparator arms expensive and the results with such a high bar will be uncertain.
Having said/ recognized that, the FDA has shown *some* flexibility and seems intent on helping the companies move forward on the trials with some streamlining improvements. I can't tell what they will do, but I would hope/expect that they will be clear about what they will need.
As you say though...this may be happening right now. Maybe the Enta Abbvie 2nd gen will be under the wire. It would make some of the acquisitions dicey; such as ACHN. It looks like retail buyers have been piling in, but potential buyers are cautiously awaiting results.
I also have to wonder; if the comparator trials were required, might (hypothetical) 2nd/3rd generation trials)Abbvie trials be able to use their own product, since they may also be considered the SOC (standard of care)?
It would seem to me that Gilead would also have the inside track since they would also possess the SOC treatments and much of the data some other companies might not have.
It is hard to wrap my head around all of this in one sitting. : )
News 
Market Data 
Discover 
