I know this is a serious inquiry, but it reminds me of a scene from dumb & dumber.
Loyd: What do you think the chances are of a guy like you and a girl like me... ending up together?
Mary: Well, Lloyd, that's difficult to say. I mean, we don't really...
Lloyd: Hit me with it! Just give it to me straight! I came a long way just to see you, Mary. The least you can do is level with me. What are my chances?
Mary: Not good.
Lloyd: You mean, not good like one out of a hundred?
Mary: I'd say more like one out of a million.
Lloyd: So you're telling me there's a chance... *YEAH!*
I think there's a chance, but that chance depends on continuing stability being demonstrated on the open label extension. And I have a hunch that GSK will find sub populations that look good for D. That would dispel the notion that exon skipping doesn't work. Either one of these increase the odds substantially.
Interesting that at this point we only have results of these serum markers for baseline and 12 weeks. Somebody knows the results from longer duration. And somebody that would know has been buying stock in the open market.
My understanding is that full scale manufacturing CMC is not required prior to P3 testing. What is important is to establish scalability of the process and stability of the product. Go back and listen to the conference call. My recollection is that the FDA had indicated some flexibility in stability testing which is where the time factor is most in play. So to answer your question, manufacturing is continuing. But the pace may be reduced now due to some uncertainty about when product supplies need to come online.
I think this is a distinct possibility. I would be very disappointed if the deal was for the whole company. And if it was a tender offer, 18 is way too low. A deal with GSK for 18/share up front with future mile stones and profit sharing would be ok with me.
I think I said it would not, not that it could not. The law is pretty clear that FDA can approve on the animal rule. The problem is that it's hard to validate an animal model. I don't believe the FDA will approve a marburg drug using the animal rule. There have been only 3 approvals using the path. One for cyanide poisoning, one for nerve gas, and a monoclonal antibody for anthrax. Siga has been seeking approval using the animal rule on its smallpox drug for years with no progress, even though the government is buying a million courses to stockpile.
Copp, I'm not changing my position. I still think there's dim hope for profit on marburg in the forseeable future. I can't imagine the government letting a procurement contract on it that amounts to much. It would be a small contract if they buy. We would need to have resurgent interest in biosecurity to get any real revenue out of the marburg drug itself.
But it remains my primary reason for sticking with the company. The government grants to develop these products help keep the lights on and demand great discipline to manage them. The government is pretty careful not to invest in companies that don't have a worthy product. A successful marburg trial helps validate the rapid-development capability of the platform. That might lead to a much bigger contract that would pay to maintain a warm-base development and manufacturing capability and provide a significant stream of revenue.
This company's greatest prospect is the platform, not just any particular product. If just one gets into the end zone it will a big deal because it will validate the chemistry. I think it was red plate who said "validation leads to valuation".
Sold everything in PM tuesday to preserve capital. Back in today to re-establish a core position. The only thing worse than taking a big loss is getting shaken out and being sidelined when it comes roaring back. This event smells a lot like what happened with ARNA when the FDA pulled rats and mice out of their hind end.
While I downplayed the bio security pipeline recently, what is important is validation of the platform wrt antivirals. Selling a marburg treatment to the government isn't going to create the kind of value this company needs to regain its market cap. But if the marburg drug works there's more reason to believe the flu drug will too. Flu is potentially a 10 billion annual market worldwide.
cigan posed a pertinent question posed by piney on IV. Why register securities earmarked for stock incentive plan now?
1) they don't intend to use the new stock for incentive pay, instead just raise cash
2) they have or will soon achieve milestones for which incentive stock may be awarded
I think most believe number 1. I think that would get them in big trouble.
I vote number 2. So if I'm right what are the possibilities?
phase 3 initiated
The incentives are probably enumerated in the 2011 incentive plan cited in the S-8 and referenced in the 10-Q
In any case I think this means an important milestone will be accomplished before the end of the year.
technically the program was refunded. But ebola and marburg are not a high priority. There is more emphasis on emergent threats, like influenza than on bioterrorism. So I would just temper my enthusiasm for anything big coming from BARDA in the next year or two. Influenza is much more likely to develop into something significant. And the government really wants broad spectrum antivirals, not one bug one drug.
I'm not saying it can't get approved. But it is going to be long and slow process that will require cooperation of african health service officials. Meanwhile project bioshield, which funded the program is over. Unless there's another incident that raises fears of attack it's pretty much dead in the water.
Not going to be approved under animal rule. There are periodic outbreaks. Doing any kind of efficacy validation is going to be problematic in Uganda. Best we can hope for is more government funding near term.
I think this brings up the same issue we've been discussing on DMD. If there was another outbreak and there was IND in place to treat humans, I think it would be unethical to only treat half of confirmed cases. In fact there is good reason to treat people who may have been exposed. Typically the disease is spread rapidly to caregivers from the single index case.
The death rate has ranged from 0-100% so how would you know if it worked or not? ( Rhetorical question)