Phase 3 is double blind study not due to wrap up until early 2016, so I wouldn't expect results to be factored into the stock at least until 1Q or 2Q 2016.
In my experience, announce the launch of expected trials rarely move the price. I'm waiting for partnership announcement.
One of the better comps I see for INO is ISIS. I think INO is probably 3, maybe 4 years out. ISIS also has a platform from which they're churning out products, and have multiple big named partners. INO products have much more revenue potential than ISIS, but ISIS practices the company/developmental model INO is moving toward.
Hate to nitpick, but we lost the more important half of the deal. I know the big pharmas want Hep B right now, but it's clear that INO wants oncology. We need to line up a Big Pharma partner for one of our oncology products ASAP.
Bad sports analogies aside (they were bad when Kim used them too), your point is valid. Losing Roche is a blow. I've owned since fifty cents pre-RS and told myself I would never sell unless there was a reason to sell. Roche gave me a reason, but I'm still holding...for now. I give Kim a lot more slack than others around here, he delivered on Roche when he said he would, and I am expecting him to deliver on the partnership promises this year as he did last. Trust misplaced? Maybe. I don't hold Kim accountable for Roche walking out the door.
Once dust settles on new partnership, then I'll reevaluate.
I don't think any news breaks on these message boards since we're all trolling the internet for sources anyway. I provided the orange book publication date only to provide a time frame in which we might hear an NCE decision (from Keryx, the FDA, or somebody else).
I'm not sure that's a fair comparison. In 2010, Jazz had plenty in their pipeline. Keryx is a one hit wonder. Outside of stock price (not market cap), I don't see the corollary.
There won't be CKD data in three months. I addressed this in another thread, but it's a double blind study that won't complete until 1Q 2016. Check clinical trials website. Your point still stands, though. If CKD indication is good, then obviously Keryx valuation goes up. If we end up waiting 15 months, during which time Keryx has nailed down its sales tactics, I might prefer they go it alone.
If, however, we can get a 100+% premium within 3 months, I won't cry about it as there are plenty of other good bios I'd like to move money to.
Why next year Dave? You think big pharm is looking for market acceptance numbers before pulling the trigger? The only hurdle that comes to mind is NCE decision. Ron has maintained that NCE is nice to have, but not a must have. I tend to agree, except that I would say NCE is VERY nice to have. Enforcing patents is an expensive process, and NCE exclusivity allows you to side step and avoid IP litigation costs. So I don't see NCE as a deal breaker for a buyout, but it may factor into the valuation. Admittedly, I'm grasping at straws here, but I am confused as to why Keryx hasn't been bought out yet.
I might also add that the trial is double blind. So we will not be getting data readouts along the way.
I'm not looking to argue, but I will correct your error. Your deduction as to the when the Phase III trial will complete is incorrect. Indeed a full dose cycle for an individual will be 24 weeks, however, that is on an individual basis. When a trial is initiated the first step is recruiting, which is a long and arduous process. The trial did not initiate with the 230 subjects pre-recruited. For estimated trial completion dates, I would direct you to the clinical trials website which provides that final data collection for the phase III CKD trial will occur in January 2016. Even then, it will take time compile the results. Perhaps we get top line data in 1Q 2016, but I think it's more likely we will see results in 2Q 2016.
With regard to whether the first couple quarters of sales are going to be informative of Auryxia's long-term market penetration, we clearly disagree. Again, I don't care to argue this point. Good luck to you as well.
The period to which I am referring is the next 6-7 months. I don't expect EU approval or completion of Phase III before then. I don't consider continued sales numbers for the first couple quarters and royalty payments as substantive catalysts, barring unexpected market acceptance. Market penetration takes time, and data substantiating market penetration takes time to collect.
My opinion is 6-7 months is a "long" period in relation to shorting a stock. As I noted above, partnership/buyout are unscheduled catalysts that could certainly happen in that time. The most likely catalysts is a partnership in the EU that may happen during this time period.
I'm long, but Keryx is a decent short play. There's going to be a long catalyst drought coming up that can effect a decent pull back in the short term. Once NCE comes through there's going to be a long waiting period before we get sales numbers.
The most persuasive reason not to short Keryx is the partnership/buyout bomb potential. Nobody wants to wake up one morning and be down 100+%.
We're in a much stronger position than Prosensa, which had mixed clinical results. a 63% premium would be a pretty big disappointment.
Any precedent on 18-month delay for NCE decision? I can't find anything longer than 3-months. Are you speaking from experience or speculating? Long delays make little sense as NCE exclusivity bars the FDA from approving or even accepting a competitor's ANDA, and long delays could cause the odd situation where the FDA must accept an ANDA because they haven't ruled on NCE. Further, there's no real reason the FDA has to wait for every indication before ruling on NCE, since a new indication would be provided exclusivity via the three-year new use/new clinical studies exclusivity.
Also, my naive self has more faith in the FDA than to grant or deny NCE based on whether they're big pharm or not. I do, however, agree that NCE exclusivity is objectively a minor concern, but am sensitive to the fact that stock price is determined based on subjective concerns.
He's ringing the bell at NASDAQ, which is in the NASDAQ studio since NASDAQ doesn't have a trading floor. I'm not sure how many people tune into the bell ringing ceremony. We already did NYSE.
We were already on the forefront of immunotherapy, it's just immunotherapy has come a long way in a year. It will get much bigger.