I spent some time pondering the whole combo/mono market thing and will share some thoughts to get some good feedback.
First, while the company has a chart indicating a $5 billion potential market size for combo (assuming all 207,000 estimated patients paid the estimated price of $24,000 annually for PRO 140), they don't really emphasize it much and their own focus is on mono. And we all seem to agree that the focus should be on mono. And they can't seem to attract decent financing - another clue that combo, despite having reached the primary endpoint of its first, and hopefully only, phase III trial, is just not setting anyone's heart a'flutter. My guess is everyone is assuming it will be hard for them to find marketing traction in combo despite the theoretical $5 billion market size. If you still have to take pills, why also take a weekly shot? Only those who are struggling on one of the classic HIV meds would potentially try it and they may be more likely to give a standard med in one of the other classes a try first. The marketing story for mono is much better - just take one weekly shot and be done with the daily pills and any related side-effects.
Second, there is no way the market for combo is 207,000 patients so they should get the ODD from the FDA. First, you can pretty much eliminate almost all of the 20-25,000 patients that are MDR as few of those will take PRO 140 and those patients must be assumed to be part of the 207,000. Second, no one really knows (I have not seen any data at least) how many patients who have two working classes of the five available are struggling with a third, but I am sure it is far less than 207,000. And many of those will likely first turn to one of the other two standard classes of HIV drugs before trying PRO 140 (simply because this is what doctors have always done in this situation and it will be hard and take time to convince them to do otherwise). Clearly, there are some patients who fit the mold but it may be measured in thousands rather than hundreds of thousands. Still, combo could find a nice revenue stream from them. Let's assume for arguments sake they can find 5,000 patients out of this group - that translates into $120 million of revenue at a $24,000 annual treatment cost for PRO 140. There is nothing wrong with that. It certainly warrants seeking approval for combo as we wait for mono.
Additionally, if for some reason mono does not get approval, you will at least not go belly up and you will have the funds to pursue other indications.
So, while I remain perplexed about the company not talking more enthusiastically about the combo market and its inability to get more traditional financing for the company's clear financial needs and given its interesting prospects, I am more encouraged about the company than I was previously when it seemed mono was all they had and that it may be some ways away from approval yet.
I am also still not clear at all about what is going on with the meeting with the FDA. It could be something very positive or something very negative and I wish the company would at least drop a few hints if it is something that has positive implications. In the absence of that, history suggests assuming the negative is the wise decision.
Financing/dilution is still a big hurdle for me. I think it is very weird for the company to be raising money right now in what appears to be a secretive fashion. I still find it odd that Tony and his crew gave themselves convertible debt but only sell equity and warrants to others. I need to hear the PE data, what the outcome of the FDA meeting is and what the company's financing plan is. The stock will be much higher if all that comes out in a positive fashion but it should still have plenty of upside left in it. If any of that comes out with a negative bias, the stock will get hit hard.
