You are correct, failing efficacy is the wrong term, but it certainly didn't pass. One reason that cancer is broken out separately because vascular leakage (what NKTR-102 exploits) may cause the drug to pass the blood-brain barrier in case of brain mets and induce opioid withdrawal symptoms.
There will be differences in the label in the EU. Subcu Relistor is to be used as needed, Movantik(g) is daily use. Subcu Relistor maintains its approval for use in palliative care patients. I don't know if Movantig will have that indication.
The study for cancer pain is no longer a black box. Study results are now posted on the clinicaltrials site. The study was terminated in 2012 due to difficulty in recruiting patients. Only fourteen patients in total entered the trial. The US label mentions "non-cancer" about half-a-dozen times.
Since we're talking Movantik, it's worthwhile to mention a few other things we've probably forgotten.
AZN is running a pediatric Phase 1 for Movantik. Completion date is January, 2017.
Movantik is only approved for patients who have been on opioids for four weeks or longer. That means no prescriptions for patients taking short course opioids for recovery from surgery. I believe there was a brief reference to this in one of the cafepharma threads.
For all OIC. Oral Relistor is still at least one year away in both US and EU.
A reminder, Movantik failed Phase 3 efficacy for OIC from treating cancer pain. Not sure how large that market is or whether it will be prescribed off label very much.
Cell change biomarkers plus $1 will get you a cup of coffee. Everyone wants some dirt simple, cheap, perhaps use at home test, to measure efficacy. A zillion biomarkers exist already, but do you base approval on them? You no doubt recall CA-125 for ovarian cancer from early NKTR-102 studies. One biggie these days is triglyceride reduction from AMRN's Vascepa. Yes it usually does, but the FDA is still requiring AMRN to run a CV outcomes study. There are many ways to look at that study. First is whether there is a correlation between the amount of triglyceride reduction from Vascepa and the CV outcome. Maybe Vascepa reduces risk of heart disease no matter what it does to an individual patient's triglycerides. Or not. This cell change stuff is all very nuanced.
OS remains the gold standard for oncology drugs.
Dilution and asset sales are two sides of the same coin. With the latter, the company is giving up future sales and profit. That reduces potential stock price appreciation.
From what I read from ASCO, the biomarker business became muddled. Drugs that are targeted occasionally work in patients who are not indicated. Biomarkers can be a two way sword. They increase the chance of success, but can narrow the market considerably.
-- "obligatory 10-k statement"
You consider the listed risk items in SEC filings as boilerplate and meaningless. They are quite real.
Dilution is pretty much out of HR's hand. If NKTR needs cash, they need cash, no way around it. Historically companies do a big hype immediately prior to dilution, NKTR is no exception.
HR states that NKTR is capable of marketing oncology drugs itself, but needs to partner pain drugs, will require a sales force beyond what NKTR can provide.
HR states that NKTR won't run another pivotal study for NKTR-102 because of resource restraints. Meetings with FDA and EMA haven't been held yet. He said that NKTR-102 approval is a long shot, given that drugs with p-value greater than 0.05 are rarely approved. Whether there is a path forward with existing data will be known by the end of the year.
Only a single NKTR-102 slide in the Jeffries presentation, buried behind Movantik, BAX-855, NKTR-181 and the Bayer candidates. Not much new to report.
-- "an indication of the path to be taken with the FDA"
That's months away. But I wouldn't be surprised if HR stated that NKTR is responding to data requests from the FDA and EMA.
No complete responses, not even a single partial response. No indication of the life expectancy of the patients undergoing treatment if given TPC rather than NWBO's injection. They used weasal words like "poor prognosis" with no data to back it up. Typical NWBO hot air. They studiously avoid running controlled trials, which is what it takes to get cancer drugs approved these days. There's a reason why NWBO didn't present at ASCO itself.
NWBO, queen of the single arm cancer studies, didn't even present at ASCO. Their presentation was outside of ASCO, though at the same location. No doubt to avoid critical commentary and ridicule at how they approach studies and present anecdotal results. But you have to admit, their booth was amazing!
Single agent IMGN853 phase 1. Seventeen patients, eight PR's, one CR.
Raising $300M in additional capital through a 10.75% preferred for a REIT this small doesn't strike me as a move that a company would make if a takeover was in the cards. A secondary for the common stock makes more sense, but that probably couldn't be done. Buying the preferred was a good short term move in April, I'm hoping that history repeats. If not, I'm stuck at 10.75%, not a bad deal at the present.
Message bears repeating... if ADK needs to pay 10.75% for capital, they can't be competitive. But I did buy the preferred below $25.50 this morning. That seems like a good deal.
imshealth collects prescription and sales data and sells it to paying customers. Occasionally data is leaked. That's how we know that Afrezza is selling poorly. Maybe someone will leak the Movantik data. Otherwise, we wait for the AZN quarterly earnings release info.
When exactly did you buy at $52? BLUE gapped from the $40's to the $70's when the ASH data was released last December and never retraced.
You guys must have shorted almost every trade at $190 and above. There were only a few thousand shares traded at that price.