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~$3B US sales, still need to put in your guesses for discount and margin.
July end point refers to end of data gathering on procedures so it sounds like they will stop doing procedures soon. Complication data will take 90 days. It will take some analyses after that to do the report so we are looking at half a year or so from now. Results may come out in symposium papers before then. They have had a lot of trouble recruiting patients because of bad trial experiences in the past. Not sure how the results will look like or whether you can extrapolate the results to non-tertiatary centers as the trial is limited to tertiatary centers where docs have lots of manual skills.
The AF data you are referring to - can you provide link to trial you are referring to. thnx.
Hospitals will have to muddle through ACA before the fog clears on capital spending on big items. It could take a few years. You don't hear about mzor because very few are out there. The highest volume center near me told me they are reviewing and uses the latest tech, just not mzor.
Why do you think there is linkage between Teva generic clearance and copaxone clearance?
It is only credible IF insider trading laws are not enforced in India. That may be the case. Still I would expect a drop in TEVA if there was a leak. Absolutely nothing happening in teva.
That is interesting. Assuming you are right that the stock is moving on approval news being leaked from the FDA, I would think there would be a negative reaction in TEVA's stock yet no movement there. Perhaps there are no insider trading laws in India and Natco makes the perfect venue for insider trading.
Nevertheless, the longer the FDA takes, the higher the odds for more than one generic being approved and diminished jump in valuation for MNTA. There is also the possibility that TEVA is negotiating with Sandoz but Natco being in the picture would make negotiations useless
Does Momenta still (ever?) have a technical edge? It seems the more I dig, the more competition I find. Even if they have an edge, it is not preventing others from coming up with biosimilars that get FDA clearance. Lovenox is first example. Same thing with Copaxone. If not, then the big prize would have to be from proprietary molecules.
There is no way Hansen can grab any market share in existing markets. Corpath is way cheaper and penetrating the PCI market quickly. Stereotaxis is already there for 90% of the EP robotic procedures. Now they are talking about going to thicker 10F sheaths for the Magellan PCI system. It is like throwing wet toilet paper to see what sticks. And they are running of money quickly. 10Q will include "going concern" statement as a result. Massive dilution coming up.
Done. Bought it all back. 4.365
Perhaps. I assumed we go below 1300 before it is over. I will probably be back in before the week is done.
Anymore new predictions? I am surprised by the weakness and GC hasn't even sliced through 1300 yet. I thought for sure miners would hold up better than gold. Started nibbling today and still 50/50 about getting bloody hands. GDX needs to hold here.
LOL. Long won't want you to shout that out again. Was long here and looking for a nice correction to get back in. Maybe another couple of days more.
They said so as of recent quarter earnings release and CC. Company is still on live support.
They still haven't file with the FDA and it will probably take 90 days after that. Any comments/reviews of Vloop from doctors using it? Not selling very well in EU despite CE marking there.
I think V-loop clearance will be great but why is it not showing up new orders. The long sales and install cycle means those that buy will for sure have V-loop by the time they use the system. Yet the sales needle is stuck on idle.
Why did they fire the CEO?
surf - what do you think of their estimate of $8000 per treatment course?
Over promising and lack of execution would sum up the year. I don't have any confidence that management will do any better for 2013. First thing they need to do is to withdraw guidance on commercial release timeline and tell us what is really going wrong and what is being done to fix problems.
surf, What's your take on repeated difficulties in achieving stable product in volume? Seems that sales ought to go well if they can make the stuff to FDA's satisfaction.
Long or short?
Hansen couldn't make it through the year clean as far as perforations during procedures reported to the FDA. The company keeps on stating in FDA filings that "it is not our fault" as the Artisan doesn't do the ablation or mapping. It only guides the catheters that do that. However, the "guiding" part also stiffens the catheter about 20 times because of the 6 extra cables and the thick sheath needed to contain the extra cables. It is liking saying the socket wrench is separate from the socket.
I am out on this bounce. I expect a revisit to recent lows as management spends more on sales infrastructure while still trying to figure out how to make the stuff.
IMO still 50/50 whether they will be able to launch KL4 by Q2 2013. Having said that, I bought some as I think the price is discounting sufficiently failure to launch by Q2. My best guess is Q3. Looking for a decent bounce above 2.
Yep. Still a trading stock until management stops tripping over themselves. CEO needs to be more energetic and less elderly.
It is still highly uncertain if the current management team can ever deliver on promises. They still haven't solved manufacturing issues and they didn't sound very confident when I talked with them. I still believe in the technology but this mis-management is stopping me from pulling the trigger.
Got around to listening to the CC. Sound like they are setting the expectation for breakeven 3 years post FDA approval so the table is set for 2015 and whatever excitement they can generate from CCAP. Like I said before, no sense of urgency on their part so none on mine.
Maybe no news is good. For example no new MAUDE filings with the FDA this year which is an improvement over a terrible 2011. I would look at device utilization as leading indicator. Last report showed they are still around 600 procedures per quarter or about where they were at a few years ago.
I sold most of my shares on this patent news. I don't get a sense of optimism, clarity or urgency from IR when I asked about penetrating the market. Perhaps they are just being methodical and realistic about the tasks ahead. At the same time they will burn cash building sales infrastructure. The train is still stuck at the station.
Utilization seems stuck despite increased installation base. They didn't have a good explanation when asked during CC. Any thoughts?
The Eskanazi's are SOL. I thought more about how Repsol got here and it must have to do with their oil price forecast back in the 90's. The agreement for them to takeover the Ypf stake must have been collared. Argentina must have agreed to downside protection in exchange of Repsol giving up upside and limit on ROR and netback. They essentially bought Ypf with shackles included that prevented them from higher cost plays with the expectation that oil prices will stay in the 1980-90s band for a long time. This was the time period when Repsol was transitioning from state run to private and I guess they didn't have the sophistication for overseas ventures yet. Unbelievable.
I could see Repsol approaching Kirchner asking for adjustments to original terms. Why should Kirchner? She holds all the cards and she is laying them down.
I don't disagree with using the cash flow for higher cost projects now that their $15-40/barrel forecast have been discarded. The value is there.
Both Repsol and Ypf were quasi government run agents at one point. This is a spat between national interests. I think Ypf will just revert to the Menem era days. I thought they were a pretty nimble company back then. Repsol was just a little weird for my taste, their willing to get cornered into a $2.5/barrel netback situation confirms that.
Ypf for example would have an easier time getting into brazil, venezuela or other LA countries than Repsol. I may start nibbling.
YPF - is the dividend safe? I found it shocking that Repsol's net back on YPF production is only $2.5/barrel. They are probably better off without YPF. YPF seems intriguing if the div is safe but I haven't done any DD on their production. Any comments would be appreciated from those that are familiar with Argentine production.
The shift of focus to vascular applications is what has me interested in Hansen. The proposition that Hansen can do electrophysiology procedures safely is iffy based upon FDA filings. The company has said that the vascular market is much bigger than the EP market so that seems to be the right strategy. What types of procedures will they do in vascular and how big are those markets? Are these related to structural heart diseases? Valves? Stents? etc. I would like appreciate a discussion if people have looked at that.
Typically, only a few percent of serious adverse events lead to deaths for both drugs and devices. It is very rare for devices used in interventional heart procedures because there is always surgical backup. I presume this would be the case for procedures using Hansen's equipment also. Seems like we are getting only a partial glance of what is happening clinically if only deaths are reported.
Go to the FDA web site for adverse event searches. Type in Hansen medical for the period starting 1/1/2011 and look at the listing. There were 6 listings for 2011 and all resulted in deaths. That is what I was referring to and would like to understand. What happened? How does it compare to standard procedure? And why do all adverse events result in deaths? IR has been of little help.
I have been looking at it. What's the story with all those deaths in the FDA filings for 2011?
Xstrata had bigger elephants to hunt at the time. Glencore comes to mind. That's been part of the picture for a while now.
how does AG fit into the equation now?
The one linked took 5 days. I don't know the relative complexity of the science.
http://delawareintellectualproperty.foxrothschild.com/uploads/file/In%20Re%20Cyclobenzaprine%20Hydrochloride%20Opinion%20May%2020%202011.pdf
Based on today's price range on the puts, it was a buy and I don't consider it huge. Huge would be a thousand contracts or more.