Please tell me that you know tax selling ends on 12.31, not 4.15. You can't possibly be that stupid.
There have been comments here and there that always imply that a drug can be used "off-label" whenever a prescriber deems fit. Things don't work like that anymore. The actual procedure is like so:
1). There is a committee that every hospital is mandated to have, namely the Pharmacy and Therapeutics Committee (P&T). This committe is make up of selected medical Staff as well as representatives of Pharmacy. When a new drug that is of interest appears, it is reviewed to see if it should be added to the Hospital's Formulary (a list of drugs that can be stocked).
2). It a drug is deemed fit to be added to the formulary, further determinations are made on whether the drug can be ordered by any Physician or if it can only be used by specialists in a given discipline.
3). Also it is determined under what conditions a drug can be used.
For example, an antibiotic like IV daptomycin (Cubicin)- at all of the Hospitals that I am on staff prescribing is for ID (Infectious Disease) only and only for a set number of diagnoses. So, for instance, someone like a Hospitalist can't order Cubicin at all. and even an ID can't order it so an earache. Although either scenario is theoretically possible, much paperwork with justification would have to be done and this would have to be approved by the P&T Chair. Not easy at all, and very infrequently successful.
That's really all I'm saying. There is an unmet need, no doubt. But active VRSA infections are rare for community acquired SSI's are are pretty much found in big city hospitals. I posted a link to VRSA data from Wisconsin- 20 cases in like 5 years, from all sources (like lung and blood).
Just PLEASE don't buy the hype from places like SA. That road leads to despair.
I should add one other thing- these trials are and have been financially supported by the makers of the Factor X inhibitors, namely Bayer, Pfizer and BMY. One doesn't see that very often, if ever.
We're thinking alike- sell the surge on the nod. DRTX will have to spend too much to promote dalba, it's their only drug (so any acquirer knows they have DRTX over a barrel, and competition is on its way with oritavancin.
No discussion of dalba here- Just a heads up on a drug that will become important in 2015.
Please check out Portola Pharmaceuticals. They are now initiating a combo P3 trial of a drug, andexanet alfa.
I'm sure even non-medical types here have seen TV commercials for Coumadin replacements like Eliquis and Xarelto. These are excellent drugs and save the patient from weekly blood tests to measure INR (also no avoiding various food items); however they have one little issue- they will moderate blood coagulation but, unlike Coumadin, they have no antidote. So if intractable bleeding occurs there's nothing but transfusions and crossed fingers.
But andexanet alfa IS an antidote. Without getting too technical, this drug takes the place of what things like Xarelto work on (Factor X), so the drug will preferentially bind with andexanet and let the normal coagulation process of the body recover. I've seen the P2 data (excellent). The FDA is fast-tracking it and ever hospital will need to stock it, just like acetylcysteine for Tylenol OD's. Andexanet alfa is given as a single dose (or a bolus and short one time infusion) so side effects are not an issue- one really doesn't care if it causes a headache it it prevents one from bleeding to death.
Do your DD, of course.
I have no clue as to what the lumpenproletariat will do if the drug gets a favorable look. Nature creates insects and fools in numbers beyond imagining.
But if it does REALLY pop, just think DNDN or AMRN.
Vanco dosing in even severe renal dysfunction is still no big deal. It must be taken seriously, surely, but can be safely used. I mean if the CrCl is something like 15 you dose it q48H. No biggy. I just wish that more were aware that Zosyn is about 3 times more likely to cause acute renal dysfunction than Vanco.
It IS nice that no adjustment seems to be needed for dalba, but this is hardly going to make it first line for MRSA.
Good luck, by the way.
I think we almost agree. Let me lay out some points (to save typing, SSI is the indication):
1). Dalba will NOT be first line for MRSA.
2). Dalba WILL be first line for VRSA
3). VRSA is very uncommon, especially in community acquired SSI's
4). Dalba will be an ID only drug, initiated upon positive VRSA cultures
5). If dalba is approved, oritavancin will also be approved.
6). As orita will be approved as a single dose, any further trials by DRTX to make dalba a one shot deal is rendered trivial.
7). Setting up sales staff is expensive.
8). Total target sales minus cost of detailing the drug minus cost of production doesn't lend itself to massive drug profit.
Nice Cut and Paste.
And "does NOT need dose adjustments in patients with renal insufficiency (THIS IS A BIG DEAL)"- No, it's not. Vanco's dose is easily modified according to CrCL. So is Cubicin.
1). "Dalvance is a lipoglycopeptide antibiotic and essentially is a long acting analog of Vancomycin and is therefor very unlikely to effectively treat VRSA." Did you mis-type? This is EXACTLY the indication for the drug.
2). "Vancomycin is given twice daily for two weeks"- Yes, it can be. But in practice the patients may be admitted for 5 days or so and transitioned to oral Zyvox on discharge.
3). "IV vanco is actually a fairly expensive drug"- it is generic and can be acquired (depending on the facilities contract) for about $150 for 10 x 1 gram vials. Very cheap- about $30/day for the drug.
4). Due to cost, even Cubicin is normally reserved for ID only prescribing. Dalba is much more expensive, and if you seriously think that the hospital will use dalba as a first line therapy for SSI's you are delusional.
5). "upcoming clinical trial"- drugs are prescribed according to current data, not what may the case in the future.
6). "patients to be treated and then go home"= as long as no comorbitities exist, which is frequently the case. Severe SSI's necessitating IV therapy isn't a headache.
I actually agree partially with you. The unmet need is VRSA, right? Please don't say you think that all cases of ABSSSI (which if you really are an ID), which on presentation are treated presumptively, will go on Dalba. So please share the scenario aside from VRSA where dalba will actually be used.
Don't mean to break up the lovefest, but for those that will follow the FDA meeting, be especially aware of the exact indication that is given to the drug (assuming that it isn't rejected outright). There are two possibilities- an indication for MRSA would be great but won't ever happen. An approval for VRSA (vancomycin resistant Staph) is what will happen. The difference? MRSA is very common; VRSA is extremely uncommon.
I bring this up because you guys are being walked down the path to unreality by the clowns at SA. I'm sure most of you started doing your sums- 1.9 million cases of MRSA times 2500USD per dose. You should instead be looking at a couple of hundred cases at whatever the price may be. And this is if it ever will get on a Hospital Formulary.
Enjoy your day!
You're welcome. That's what hidden longs do- badmouth the stock hoping it will go down in order to buy more. Shorts are those that talk up a stock before an event hoping that it rallies in order to bag more gains when it tanks.
You guys always think in reverse for some reason (rookies).
That's the funniest comment ever! Pfizer dumped this dog for peanuts because they are the only ones who know why the FDA did not approve it.
But you guys will find out quite shortly.
Maybe her husband needed a copy of his Birth Certificate and she's picking it up in person.