Given all the breathless headlines in the earnings release. Facts are that wireless margins are falling and the Leap acquisition looks like a major failure.
In an adjuvant setting. Stock triples AH. This is what will happen to NKTR in the unlikely event that NKTR-102 MBC extends life two months plus compared to TPC. Equivalent OS with reduced AE's are all NKTR really needs for approval.
More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial.
The primary endpoint of the trial was disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.
If the FDA requires data that APPY doesn't have, you could be looking at years and $M's to run further studies. Need clarification from the company.
APPY got a CRL. This is from the FDA web site.
"A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA)."
What you people seem to ignore is that the FDA asked for more data. In other words, the data APPY supplied is insufficient for approval. It is very likely data that APPY doesn't even have, otherwise it would have been submitted in the NDA.
"Venaxis is compiling responses to the FDA's questions and their requests for additional data and information"
Even though the company deftly avoided using the term in the PR.
Pending SLXP/FDA agreement on labeling and post-marketing study. Good for PGNX, milestone payment coming, unless SLXP screws it up. I'm not sure the this will carry over to oral Relistor.
This bodes well for Movantik approval.
Here's a case for buying bluebird bio (BLUE).
You might have heard of the hereditary disease beta-thalassemia (BT) major. With this disease, the body produces defective hemoglobin. People born with BT major are condemned to a life of frequent blood transfusions. That causes numerous problems, not the least of which is excessive iron which has to be removed through painful procedures. The only curative treatment is a bone marrow transplant, but that requires a very close match to be successful.
BLUE has developed a virus that "infects" bone marrow cells and causes them to produce normal hemoglobin. The procedure is to extract bone marrow from patient, expose it to the virus for two days, then reinject into the patient. Because the patient's own bone marrow is used, there are no rejection problems. The procedure was tried on two patients about seven years ago. One patient became transfusion free after six months and remains so today. The second produced some good hemoglobin, but not enough to completely eliminate the need for transfusions. Recently two other patients were treated with a second generation virus. -- Both patients became transfusion free after *two weeks*!
BLUE is treating several more BT patients now. More importantly, BLUE is testing the treatment on patients with sickle cell disease, which is caused by different defect in the hemoglobin molecule. Like BT, sickle cell disease causes a multitude of problems and can only be cured by bone marrow transplant. Preliminary results of these trials should be available by the end of the year.
If the results confirm, BLUE could be a multi-billion dollar company. A year from now I expect BLUE to trade at either $100+ or less than $10 per share. There are other applications in the pipeline, but nothing that's going to pay off for a long time if at all. I have about 5% of my money in it, all I'm willing to put into a speculative biotech. You may want to consider it.
Good luck all!
It could be something fixable like Omontys... no wait, Takeda gave Omontys back to AFFY, and the AFFY BoD decided to dissolve the company.
Most of the Q1 GDP decline was due to a dramatic drop in health care spending. A hospital REIT may not be the best investment despite the yield.
So what happened in the first quarter? Evidently, several things. Number one, if you haven’t noticed, the deductibles for most of the ACA programs were quite high, often running as much as $5000 (which, for what it’s worth, is the deductible on my own insurance program – buying a lower deductible is significantly more expensive than simply paying the higher deductible. Go figure.)
The high deductibles were a shock to many people who were used to more-traditional health insurance. They postponed some services and started looking for transparency of pricing for the more expensive services. It is no longer uncommon for a patient to ask for a prescription for an MRI that they can take to another provider across the street who will charge them half of what the hospital provider will. If you’re paying it out of pocket, you begin to pay attention to what you’re paying.
Further, there were a lot of people who didn’t get Obamacare insurance in the first few months and had to wait until March or April for their insurance to kick in. Other people have lost their insurance inexplicably because insurers are losing control of their internal management systems amid all the turmoil. People are postponing what they can until their insurance kicks in or gets reinstated.
I still think the next shoe to drop may be in the third and fourth quarter when hospitals begin to realize that they have significant cash-flow problems. Estimates are that we have about 10% too many hospitals, and the creative destruction of the new healthcare system is going to relieve us of that excess. Only the strong and well-managed will survive. This is of course going to create turmoil in the whole healthcare employment world, etc., etc.
I'm with you corona. FEV1 to get a script, another FEV1 at six months to get the script renewed, then FEV1 annually to keep it renewed. If mm is correct about it being used as an alternative for special occasions, then sales are going to be poor. The big bucks come from daily use at every meal. It's hard to see big pharma stepping up with that black box warning. Would MNKD really try to build its own sales force? It looks a whole lot like AMRN right now.
FEV1 typically means referral to a respiratory therapist. Now required for each and every patient before being prescribed Afrezza. Good luck with that.
FEV1 is typically done by a respiratory therapist, not your GP who prescribes insulin. That means a separate appointment with a referral. It's now required for each and every patient before being prescribed Afrezza. Good luck with that.
How many insurance companies are going to pay for this for an insulin prescription? How many doctors are going to do this? Not many I'm guessing.
BOXED WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination and spirometry (FEV1) to identify potential lung disease in all patients.