Joe, your post brings up a host of other interrelated questions. None of what follows is intended to disagree with what you've said, but instead, to use it as a "springboard" for other issues.
"I do feel that AW will be around even after FDA and that she will use them for interim money until the Nasdaq listing."
And why not? If only as insurance. But if we get FDA approval, then won't we also get some JnJ money, upfront? I know estimates vary widely: mine was lowish, around $4-5 million US, with later milestone payments. Others have been as high as $20 million, US.
And then, what about revenues from "filling the channels"? Say, 100,000 bottles (2,000 per state, roughly:conservative)at $20 CDN to DMX, that's $2 million CDN.
Then there's the question of the WF10 partner. IF the P3 results are what we expect, and IF we get Priority Review - and IF WF10 gets labelled not only for HIV, but later for all immunodeficent conditions - how much would that upfront payment be?
I'd like to put before the board the interesting problem that occurs with WF10. Just for the sake of the discussion, let's say that WF10 gets labelled and approved for late-stage HIV cases, in Priority Review.
Concurrent with that would come recognition of the BMAH, and the recognition that WF10 will be efficacious in a wide range of conditions - from asthma to some cancers, to Crohn's, and so on.
What could conceivably develop is a situation much like the one that developed with AZT: the FDA was simply unable to stop its widespread use. (This is aside from the serious problems that attended the initial trials and stats on AZT).
Once this collection of conditions becomes labelled as "Immunodeficient Conditions" instead of the separate conditions of asthma, prostate cancer, etc - what happens to WF10 sales? How will the FDA control it? The safety of WF10 is already well-established, as is the optimum dosage and timing - so what is to stop a physician from using some for off-label usage, for any given immunodeficient condition, of whatever name?
I mention this because it's a consideration that must be borne in mind by both DMX, and a potential partner - and one that has important ramifications for revenues - and therefore, for a possible up-front payment.
Anyway, my overall point is that sources of revenue might well be greater than we have anticipated.
If WF10 results are what we think they may be, it may even negate the necessity of listing on NASDAQ!
Regards,
Jim |
