Just my opinion as a licensed physician -
1. Interferon as part of a regimen is not a big deal, given that treatment courses are only 12 weeks now (previously 48 weeks, most patients I've seen that fail last at least 2-3 months). Honestly, i don't care about nonfatal flu-like side effects as long as there's a cure.
2. I wouldn't prescribe any new regimen that has not been proven in a head to head trial that it is superior to or at least non inferior than standard of care, which in HepC is now Incivek/Riba/IFN. I'm pretty sure the FDA agrees.
3. I think that in 2014 when physicians have experience prescribing Incivek for 2 years, it will be difficult for mass switching to a regimen without Incivek without direct head to head comparisons proving superiority. Even if an IFN-free regimen works, why eliminate from the regimen a drug that works?
I understand Wall Street's current view, but sorry, they're not doctors
Are you a licensed physician that treats HepC patients?
It seems that everyone claims that Interferon is "terrible" but you appear to question it.
The FDA will not require a side-by-side trial with Inciveck, just the old SOC. As long as the SVR are close to the Incivek regimen, the new drug will be approved
1. Interferon main side effect is the "flu-like symptoms" about once a week, good acetaminophen or ibuprofen takes care of much of the patients. 2.At least, a "non inferiority" trial will VRUS need to get their oral combo into acceptance. 3. a "superiority" demonstration trial will be the crown jewel for VRUS. 4. VRUS "hedge" is a lot of multiple trials combination in phase II, then to go to phase IIIs in the "interferon intolerant" patients, a category not different to treat in turns of the virus, just a trick to avoid a regime including Incivek THE NEW STANDARD OF CARE !!!
I am an internist, not a hepatologist, but I have many patients with HCV and work closely with the Liver specialists in coordinating their care. A few points though: yes, IFN is not pleasant, but it is not of the black-label type side-effects such as MI, etc. that kill drugs.
I do agree though that the FDA may accept Phase3 trials against IFN/Riba only, but then again this is speculating what a committee 2 years from now is going to believe is acceptable. I do think that there is a significant chance of restriction of label-use given that Incivek regimen will be out almost 3 years, that is that the approved label for "All Oral" will be only for IFN-intolerant patients (remember, this generally means patients with contraindications to IFN such as depression or autoimmune disease, or fail treatment w Incivek, not patients who simply don't "feel" like they want to take IFN). Also, there is NO way that the FDA would approve a label for type 1 if the phase 3 type 1 enrollment is not large, this would be breaking significantly with their conservative approach of the last decade.
But mostly I feel the reason why Incivek won't fall off the map is that it has 2-3 years to become standard of care. At my tertiary center at an ivy league institution, it is already standard. If you understand anything about the medical practice and constant legal threats of malpractice, it is that physicians are extremely conservative in general, and are normally resistant to change in treatment patterns unless there is clear data that indicates substantial benefit. Now of course it is possible that one of these nucleosides ends up being the magic pill, but for that to happen it would 1) have to be proven to work in Type 1 patients in a large phase 3, 2) be approved with an unrestricted label, and 3) have clear or strong evidence that it is substantially better than current regimens, without any toxicity (remember, we physicians are well aware that toxicities often are not uncovered until post-market Phase IV, see Avandia, etc.) All of this IS possible, but I wouldn't stake my money on it.
Interferon has been a mainstay of HCV therapy for decades, with extensive trials showing its efficacy as part of regimens against type 1 HCV. Although it is an unpleasant treatment, it does not kill anyone without contraindications. When a new drug comes out, doctors don't immediately swarm to the newest shiniest thing, with the least data; we're not talking about Ipads or Iphones here, we're talking about peoples lives and at the end of the day, my own malpractice risk.
you don't get the doctors point!you can't walk into a doctors office and tell the doctor what you want and don't want.they decide what kink of treatment you will recieve according to standard procdure.Is this not correct doctor.I posted earlier 15 of the top hospitals in the US and perhaps 1 of these is one that the doctor is talking about being in contact with.My doctor in my home town is in contact with one of those mentioned.This stock is being controlled right now however,whoever,whatever but it is controlled. they can't controll forever just a matter of time and patients
I hate to put this bluntly, but the patient does not choose the treatment, only the physician does. It matters very little what the patient believes, only what the physician is willing to offer. Medicine is not a department store.
Physicians have enormous power over prescription habits, why do you think Pharma targets doctors with their army of reps?
You can counter that the patient can go to another doctor that is willing to write the script, but if your argument is resting on the majority of doctors just prescribing whatever patients want as the basis for why Incivek will fail, then we can disagree about that point. If that were true in medicine, then we wouldn't need licenses.
We've had plenty of good news, it doesn't seem to stop the heavy selling. Face it,institutions control this stock PERIOD. VRTX has been in a downward spiral every day for weeks on end and it
boggles my mind that management fiddles away much like Nero when Rome burned. We as stock holders should be writing letters to the CEO,CFO and BOD showing our disapproval.
One other point. The class of people that congregate here on Yahoo finance are generally people who are interested in the stock market. And in the case of this board, people who watch biotech closely and are not ignorant of the wide variety of treatment choices out there for any given illness. But I don't think that's a fair representation of the typical patient, who will likely do what ever their dr tells them. Sure they might do a little casual reading, but they are not going to say hey doc I've heard about this drug entering p3... etc and have the dr change his mind. The dr is going to advise the current soc. Any dr that advises a patient to wait 2-3 years for a drug that may or may not pan out should removed from practice. Especially when the current soc has such a high cure rate.
This entire competition based destruction of VRTX's market cap is very suspicious. I have seen future competition effect a stock price, but never to this extent, especially something that is still very far out. Perhaps we should reduce VRUS's market cap for the the inevitable over the counter Hepc treatment in 10 or 20 years? I mean when does the stock benefit? How long is safe? 5 years? 10? It's ridiculous. I think something else entirely is going on here. Whether it is manipulation or killer bad news that we don't know about or whatever. But the idea that we lost half our cap because someone might have a pill in three years is just dumb. The world might not exist in three years lol. Very frustrating.
Agree this stock has always acted strange at times, I have a friend who works for them but I dont know anymore than the folks on the board but I do recall the stock acting strange and then moving back up for not many substansial reasons also. Now that the heavy lifting has been done and the cash is flowing in no reason to jump ship. I recently purchased some shares and wil hold them. although the chart looks ugly. Joe