I'm seeing even a bit less than that but similar.
I think Abreva royalties stopped (given the low level of payment last Q) but at most they'd have 2 weeks' worth in April.
Thanks for the heads up. The only difference I see is the capsule counts and the description of the Optinose device: "Device is fixed at two points (nose & mouth) - Less vulnerable to hand movement at release"
Nothing else different that i can find. Can't figure out why they put out a new presentation. They've only been doing it in association with their presentations and I don't see any coming up.
Why do you think sales revenue will beat? I hadn't really looked at it before but I remember Bert saying it looked ugly. On first glance I'm agreeing with Bert.
Analysts are currently projecting $30.05M for net revenue. I expect they will revise that down before the report.
Ketamine comes in a powder form and one of the issues identified in this study was an inability to achieve the same blood levels of ketamine with nasal administration as with IV. One would expect the Optinose device would help augment the bioavailability and it would be an awesome 1-2 punch if AVNR were to license the Onose device for nasal ketamine administration and then be able to offer dDM as follow up longer term therapy.
Obviously risky at this point since there's no direct evidence dDM will work...but one can fantasize.
Conclusions: This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine. Treatment was associated with minimal adverse effects. If replicated, these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression.
I'll try to get the full article
Thanks Falconi....The associated journal article is about to be published:
A Randomized Controlled Trial of Intranasal
Ketamine in Major Depressive Disorder
Kyle A.B. Lapidus, Cara F. Levitch, Andrew M. Perez, Jess W. Brallier, Michael K. Parides,
Laili Soleimani, Adriana Feder, Dan V. Iosifescu, Dennis S. Charney, and James W. Murrough
Background: The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid
antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and
efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.
Methods: In a randomized, double-blind, crossover study, 20 patients with major depression were randomly assigned, and 18 completed
2 treatment days with intranasal ketamine hydrochloride (50 mg) or saline solution. The primary efficacy outcome measure was change in
depression severity 24 hours after ketamine or placebo, measured using the Montgomery-Åsberg Depression Rating Scale. Secondary
outcomes included persistence of benefit, changes in self-reports of depression, changes in anxiety, and proportion of responders. Potential
psychotomimetic, dissociative, hemodynamic, and general adverse effects associated with ketamine were also measured.
Results: Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t 4.39,
p .001; estimated mean Montgomery-Åsberg Depression Rating Scale score difference of 7.6 3.7; 95% confidence interval, 3.9–11.3).
Response criteria were met by 8 of 18 patients (44%) 24 hours after ketamine administration compared with 1 of 18 (6%) after placebo
(p .033). Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with
clinically significant changes in hemodynamic parameters.
Chronic migraine treatment (as you know)...now if they only had something novel for acute migraine ;)
do you know which of these are newly posted?
Roy, do you?
Agree expedited is an important word though I'm not sure of the meaning. They may be referring to one of the 4 formal expedited FDA tracks to approval (fast track, breakthrough therapy, accelerated approval, or priority review) or they may simply be using the term to describe the already given approval to use AVP923 data to support the use AVP786 thereby allowing bypass of several Phase I steps. Prior related press release below:
June 5, 2013
LEXINGTON, MA – Concert Pharmaceuticals’ partner Avanir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for AVP-786 (previously known as CTP-786), requiring only a limited preclinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies Avanir intends to proceed directly into human clinical trials.
"We are very pleased with the outcome of our recent meeting with the Division of Neurology of the FDA," said Joao Siffert, MD, Avanir's chief scientific officer. "Avanir will be allowed to reference the extensive data generated during AVP-923 development programs in support of the AVP-786 IND and subsequent new drug application. This has the potential to substantially reduce the cost and time to market. We anticipate that we will be able to seamlessly integrate AVP-786 into our ongoing development programs in neuropathic pain, agitation in Alzheimer's disease and levodopa induced dyskinesia in Parkinson's disease."
We need to consider AVNR's gross wholesale price not the retail price. Wholesale/pill is $10.75
Gordon's $155M net looks close to expected burn + cost of product sales. It's probably close but added to that will be costs of interest on their loan, costs of options for employee compensation, and depreciation.
Not sure how you came up with your premises but I'd approach it as follows...
The current gross/pill is $10.75. The net per pill is simply the gross less the discount. KK gave guidance for the discount which I forget currently but it's been 23-25% recently ($8.06-8.28/pill)
This week's gross run rate is $137,645,000 which would translate to $103-106M for net run rate using a discount of 23-25%..
Interesting point Sarge...maybe this is why AVNR will run the depression trial with AVP786 (dDM) and not DMQ. Not sure that fully gets them around issues with CNS though since they will still use some Q. I'm sure you are right they can work it out.
He was a prisoner of war...are there any POWs that are not considered enemies of the state?
He's been convicted of multiple murders..the most famous of which is the murder of Hugo Spadafora: "The autopsy later found Spadafora's stomach full of the blood he had ingested during the slow severing of his head. He had also endured hours of severe torture, as is quoted in Gary Webb's Dark Alliance: "His body bore evidence of unimaginable tortures. The thigh muscles had been neatly sliced so he could not close his legs, and then something had been jammed up his rectum, tearing it apart. His testicles were swollen horribly, the result of prolonged garroting, his ribs were broken, and then, while he was still alive, his head had been sawed off with a butcher's knife." His head was never found"
I guess it's the kidnapping part that gets to him ;)
Thanks neuronrancher...not even published yet ("uncorrected proof"). Nice find.
Bodes well for the treatment resistant depression study also
Most will remember that Greenspan's "irrational exuberance" remark ushered in 4 years of one of the best bull markets ever. S&P more than doubled in that time and the Nasdaq quadrupled.
I suspect CNCE is still haunted by GSK backing out of the CTP-499 deal and they are further penalized by the early stage of their pipeline. That being said, I see the value of the components as undervalued, esp. the AVP786 one. Also, as you noted, they have limited development costs and can continue to pump out drug candidates with the deuteration platform. This company currently has my full attention.
Like all of wikipedia it may be useful if you are looking for basic information. As such I think it's a fine first approximation. That being said, the above passage (like most prevalence proclamations) suffers from not first defining what they will consider PBA. Instead it considers PBA to have a uniform definition while discussing studies using differing standards. In addition it's inadequately referenced with the incorrect and unreferenced assertion that the 2 million number comes from an "online survey". It carries no weight or import and anyone can go in and edit it..