Well, it's been a frustrating August, watching the Keryx paint dry.
We now have three choices left for (we hope) approval-announcement timing before PDUFA target date of Sept. 7:
(a) late today or early tomorrow--meaning that our big day is a Friday in late August (bad, bad);
(b) next week -- the last week in August before Labor Day weekend (possibly even worse); or
(c) the week after Labor Day.
At this point, simply for PR value, I prefer early September. People will be more focused on the markets and on medical news. At this point lots of investors are still at the beach.
ebbr, you are correct. Japan has approved both; the application to the EMA is for both; but the NDA to the FDA is for ESRD only.
Now what does this mean? It means that Keryx cannot market off label; that is, Keryx cannot market Z for NDD-CKD. That said, assuming the drug is approved, doctors will be free to prescribe it for NDD-CKD if they deem it medically appropriate. (How insurers will react is a whole other question.)
So the $64K question is how much off-label prescribing there will be. Once the docs see how well it works for people on dialysis, will they prescribe it in large numbers for NDD-CKD too? Only time will tell.
What do you mean "approval with pre dialysis"? The NDA is for ESRD only.
Yes, some prescribing off-label for NDD-CKD will take place. But in this context, the only thing to be approved (we hope) is the use of Z for ESRD.
Cerdelga will benefit only 6,000 patients in the US. A good drug to approve in late August.
Color me cynical, but I'm starting to wonder whether the FDA might want to approve Zerenex in September, to make a bigger public-relations splash. Just in terms of patient and economic impacts, this could be the most important approval of the year.
And there are political ramifications too. A Zerenex approval would be a useful reminder of the FDA's importance, during appropriations season on the Hill. And the announcement will have broader policy implications, as it could substantially shift the Part B cost curve.
Washington players do not bury their good news. And a Zerenex approval will be very good news for the FDA and for HHS generally.
Look, I can justify a price of 40 with my hands tied behind my back.
100K US patients x $10K per year = $1B revenue x 4 = $4B mkt cap / 100M shares = $40 per share
Of course 100K patients is ridiculously low; that's just a start.
And there are other countries in the world besides the US. In case you hadn't noticed.
Oh, well. It's 5:10 and we're not halted, so I will pay no more attention for today.
On the bright side, only 12 more trading days until Sept. 7. Assuming an even distribution of probabilities, the chances are 8 percent for any particular day, and rising.
Also the profit-seeking shorts are exiting as best as their computers can manage -- which is pretty well for them, as the conviction buyers are already in the stock.
(Profit-seeking shorts as distinguished from the hedging shorts, who might want to be short through the announcement.)
"It's gotta be this week."
Depends on whether Keryx is trying to play a PR-scheduling game, using the label dialogue to push the announcement back until after Labor Day.
I'm not saying they should; not saying they shouldn't. I'm just saying that there might be a strategy/reason for wanting a slight delay at this point.
The end of August is a terrible time to announce good news.
Half a million shares traded in the first hour, and we are down more than one percent while the rest of the market is up one percent -- XBI and IBB are up more.
Ron, would you please just cut to the chase. Thank you.
Good point. But I have to suspect that some of the shorts are the very institutions that have taken long positions too. So they will buy to cover. And it's true; they might well hold long term.
But more important is the market's overall appreciation and understanding of Keryx. That will change this fall, with (we hope) approval, commercial launch around Kidney Week, first full quarter of sales in Japan, and early sales in the US.
Assuming approval, there will be more focused analysis of Keryx's potential, and a greater realization that (assuming approval) there's a lot of value here.
Price targets will rise, of course; but price targets are usually only for a year out, and might not capture the total picture. Summer 2015 is when things get really interesting, with EU approval and NDD-CKD SNDA.
So I'm looking forward to some serious analysis, and more widespread understanding, of what the stock might do 2-3 years hence. And I think that analysis might take place with approval, and that the understanding could very soon become more widely held. Like the stock itself.
Good thought but it's now past 5pm with no news.
I figure that if they knew for Monday, they would have announced today (to get tonight's news as well as tomorrow's).
Therefore I infer that we won't hear anything tomorrow morning either.