re: Ann: Letter to Shareholders from the Boar...
Hey Worthind,
I have looked into expanded access several times and never have I been able to see it as a money spinner. Even when I looked at it last month.
Expanded access is good to help 'prime' the market, but unless you have a viable path to regulatory approval it is likely to do squat for you, from what I can tell and have seen.
If the powers at be want to displace 3TC, two phase III studies will be required. Changing to an orphan indication, if you can get one, will change those requirements substantially.
The basic difference between our view points is that I believe Coates and Chick have exhausted all avenues with ATC, while you obviously don't.
I agree, forget Drona in terms of finding a market for ATC. Having said that, I don't think the new guys are likely to be any better.
The best guy in Australia you could have in the area is Coates and he is now no longer with Avexa.
I would simply see if you can get Drona to, at least, outline what has been done in terms of orphan indications. A good place to start is simply by asking whether they have submitted any applications over the last few years for orphan indications and, if so, what were those indications. While you can find a list of those indications that have been approved and I am yet find find one of those that have been knocked back.
Cheers,
Bob
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