One other thing- what I really am waiting for are C. diff trials on dalbavancin and oritavancin. Positive results here would be very large indeed.
Regarding tedizolid, so far we only have trials vs Zyvox for cellulitis. The P3 pneumo trials will be going on for quite a while, and until it is shown to be superior to Vanco nothing should be concluded. But even if non-inferiority is demonstrated, as these HCAP patients will be admitted there is no way tedizolid would be preferred to Vanco just on a cost basis. And I'm sure it would be an ID prescribed only drug.
And do you guys really just start someone on Vanco and just turf them off to Outpatient immediately? Yikes!
Answer is both not much and a lot. Both are similar in effectiveness against MRSA and enterocoocci. Oritavancin is more potent against VRSA. Oritavancin is given once, whereas Dalbavancin is given weekly x 2 doses. Dalbavancin has to have the dose reduced in severe renal disfunction, Oritavancin does not.
Oritavancin caused a mixed-lipid storage disorder in animal models, but hasn’t been seen in humans. It will also elevate liver enzymes to some extent, but without any hepatic dysfunction. Dalbavancin really doesn't have any significant adverse reactions. Oritavancin showed activity against Hospital Acquired Prneumonia (HCAP) in early studies; no such studies were done for Dalbavancin.
That’s it in a nutshell- Hope it helped.
Have to disagree regarding tedizolide. The trial was against oral Zyvox, which isn't first line for ABSSSI. After discharge, continuing on tedizolide, certainly. But as a replacement for Vanco or Dapto? Never.
It's really easy- tedlizolid is a second generation oxazolidinone antibiotic, so it's much like Zyvox (also comes in oral and iv form). It is given once daily. As it can only be said that tedizolid is noninferior to Zyvox, it can be inferred that it would be used in the same way- either as a switch from Vanco when the patient gets discharged from the Hospital or as first line therapy for those rare folks that can't take vanco. It cannot be considered a competitor to DRTX.
What makes dalvacin special (as I'm sure you know) is that it's only given once weekly x2 and inpatient admission is not necessary. The only thing similar on the horizon if oritavancin and the FDA isn't ruling on that until August.
I've been buying for a bit for the simple reason that the market for this drug if approved, will be rather large. A quick indication of how large can be seen by checking what happened to the market cap Cubist Pharma due to Cubicin; granted they have other products but Cubicin alone chipped in about 900 million in Sales last year. Cubicin can also be given to those with cSSSI without hospitalization needed but is a daily dose.
And of course I have MDCO whose oritavancin (PDUFA date for oritavancin is August 6, 2014) also looks extremely good. But MDCO won't be bought out on approval- DRTX will.
GD- I guess you are referring to what I brought up previously. The reason I did so is that speaking to ER physicians who would prescribe the drug frequently (I'm also a Pharmacist- Hospital) voiced this concern. And as Durata hasn't broken down what exactly the adverse reactions were that caused 2.4% to drop out of the trial (vs 1.9% vanco arm- statistically significant), this concern may or may not be valid.
Just didn't want anyone going in blind.
The half-life is so long an Epi-pen would be inadequate, and diphenhydramine really isn't the ticket for severe allergic reactions as I'm sure you're aware.
The discontinuations due to treatment emergent adverse events was 2.4%. I wish they would list the reasons so we don't get blindsided.
It will absolutely save cash. No 7 to 10 day hospital stays, no daily lab draws to check serum creatinine, no monitoring CrCl by Pharmacy. The only concern I have about uptake of the drug is what makes it special- the half-life. Will prescribers feel comfortable that no allergic reactions will occur? And if they do, what can one do? An Epi drip for a week?
Sentiment: Strong Buy
Looking at how Cubist did after the approval and uptake of Cubicin (also pretty much limited to cSSTI), I feel estimates for DRTX are unbelievably low.
The March 47.5 Puts were definitely purchased, but what isn't known is if they were naked or a hedge against loss from existing shares held. Option volume data always leaves tidbits of information like that out (not that it could be determined if that was the case, but one shouldn't jump to possibly erroneous conclusions).
I don't know why everyone thinks that when a contract trades it has to be purchased at the Ask instead of sold at the Bid. Just remember that a option sale will also up the open interest.
If you notice the volume inscrase started shortly befor noon on Friday, not doubt by someone tipped off to the Moragn Stanley upgrade today. I saw one block (5 thousand contracts) of what was a covered write cross Friday on the ISE where 20 thousand of the 26K traded..I didn't see the others cross, but I bet they were from the same trader.
To see what will happen to MSTX over the next few days, look at RNN. This one was also in the 50 cent range last week, had big buying (over 20 million shares) on Friday and jumped up to 1.60 today on volume of 78 million.
MSTX was in the 50 cent range today, jumped on 20 million plus volume today and should follow through over the next 2 trading days. So watch RNN to see when to dump MSTX.
So they were in-line with estimates and justifies the current PE. So much for a massive rally.
Qihoo has had an English version of 360Safe, and it is actually very good. Formerly it was easy to download, but for the past 3 weeks it is virtually impossible. The installer is 192MB, and the website has been so slow that it would take at least 6 hours to download the product, which obviously not many will do.
Can't understand why this is occurring.
To me it looks like a pullback to the 9.16 area is indicated (the top of the gap from Sept). Best long play if that happens would be the Nov 9, 11 call spread. This should be available for about 50--60 cents with a possible triple if ramp-up guidance is good.
Most of the 12's were sales. The volume of the Nov 10 contract is higher and those were buys. so looks like most of rge volume was a spread. Yesterday the Nov 10/12 spread was 65 cents. Today 45 cents.
Your better off waiting until everyone and their dog knows about it, then buy, buy, buy at $50.