Physicians don't need permission for off label use.
Permission from the FDA to AVNR to market it for agitation will take the full FDA approval of the indication...and from the last conference we can expect they need at least one more PIII trial for that.
Wrong on all counts. It's very clear you have no understanding of this company or the diseases it's drugs treat now or in the future. "Treat agitation in PBA"??? ...please, you can't even make a sensible statement. You have to know you don't understand what you are saying so your dire conclusions must be motivated by something other than knowledge/understanding...and I think we all know what those motivations are.
Abreva, monoclonal antibodies, anthrax...those are all part of the company's history with no active programs and no expectation of revenues in the future so your silly arguments against these are hardly relevant and clearly show YOU have not done your homework. Go away.
Abreva? Anthrax? Do you even know what this company does?
Yeah, I marked this post...much like my dog marked a sign post this AM.
Ok, I guess your point is that a component of Nuedexta is also used as a cough medicine. Do you realize why dextromethorphan alone can't be used for CNS disease?
Serious question...what point do you think you and others are making when they say "NyQuil is approved" or "Neudexta is cough syrup"
Is this just a slogan or do you think there is real validity to these statements?
All the news related to agitaton is now out. Many bought to capture that spike and are not interested in mid to long term. If you like the rising N sales, Optinose prospects and the general market doesn't turn your stomach then their exit might make it a good time to get some.
I am not intimately familiar with either scale though I'm sure I'll be getting more info as the trial proceeds. However, I think we can infer just from the name that the Cornell scale is exclusively used for a demented population and would therefore not be appropriate for the main depression trial.
yes...there was also a thread here on the AVNR board yesterday with this same title you may want to look up.
I was disappointed they glossed over the depression finding this morning...no real comment at all. It seems particularly striking to me in that this effect was present and patients were not chosen relative to their depression status so many were likely not depressed at baseline and therefore there would not be much room to impact the Cornell scale. Any effect seen must have been on a likely minority of the patients. They mentioned this morning that about a third of the patients were already on antidepressants at the start of the trial.
AVNR has said repeatedly that future trials for all indications will be with AVP786. They have said specifically that PIII for agitation will be with AVP786. They have already started their depression PII trial with AVP786.
They can always change their minds but we can be certain of their intent as of when those statements were made. I think it's exactly your concern that is holding CNCE back and creating a great entry point.
Is there a risk?...maybe, but I don't see why they'd give up on their AVP786 investment with better safety and longer patent window. That being said, Baral referred to peak sales of "923" AVNR's 1st generation d/q drug...I think it was just an oversight and AVNR has no plan to bring 923 to market for any new indications. AVNR has a webcast starting right now...listen for yourself!
I don't have any particularly educated guesses...others here could do a better job of estimation I think
@crstimator ...you are correct, I've gotten a bit carried away but no worries, I'll be back to my dour ways in no time.
Cowen's Ritu Baral is saying peak sales of 1.3B for agitation.
If CNCE gets 8% (I think at that sales level it will be even higher than 8%) then they make over $100M/year in royalties or $5.77/share. Their marginal cost to collect those revenues?....$0
Both agitation and depression results impact Concert Pharmaceutics as well. Their management has done almost nothing to publicize that impact so if AVNR doesn't spill the beans tomorrow morning it may be worth a look before it's "discovered".
So expenses double to $300K/year...leaving $1B in profit or $5.85/share
A pittance!...better get another couple billion from depression to make this all worthwhile!
Both agitation and depression results impact Concert Pharmaceutics as well. Their management has done almost nothing to publicize that impact so if AVNR doesn't spill the beans tomorrow morning it may be worth a look.
very strange...I don't think they plan to submit 923 for approval. She should know that...wonder if it's an oversight or if something is up.
I don't think AVNR avoids it at all..there is just not much reason to continue to repeat what they've said in the past. The quiet ones, IMO, have been CNCE's brass. They did a very poor job of explaining that AVP786 would be used in agitation...AVNR announced it about 9 months ago and they were quiet (which created an awesome opportunity to buy AFTER the data was out!...so I'm not really complaining). In addition, they did things like list the maximum value of the AVNR deal as $170M without being clear that that was only milestone payments and royalty payments were uncapped.
Cornell Scale for Depression in Dementia (CSDD): p=0.02
I think this point was missed by most...but when you realize this was not a trial for depression, the patients were not all depressed, and the drug STILL reduced depression it bodes incredibly strongly for the AVP786 depression trial.
In addition, the market STILL doesn't understand the impact of AVNR on CNCE but tomorrow AVNR will have an investor conference where they should be reiterating their intent to use it on ALL their trials going forward. I think it's going to be a good next 24 hours.
Also, need to remember this was not meant to be a depressed population at baseline...and they STILL showed an improvement. This aspect just hit me and I'm a bit shocked by it.