...or know that they are selling on the correct side of the move
...or have correctly weighed the probability of the move in each direction before placing their bets
Percentages are huge because, in probably less than a month, the pps will be either $6 or under $0.50 (give or take).
Anyone selling options right now should have a really good reason as to why the above assumption is wrong.
Thanks TR...for those interested if you google "Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review"...select the first result...then click the free article icon in the top right you will truly get "more than you want to know about nasal devices".
I had never heard of the transfer of molecules from the venous to the arterial system within the cavernous sinus so I looked for more detail They have 2 references but unfortunately 1 of those references suggests that this will not apply to sumatriptan. Not that it really matters...there's no expectation that would be needed/helpful.
As an aside...Mannkind's Afrezza is inhaled...meaning it's a pulmonary delivery system not a nasal delivery system...the absorption primarily occurs in the lungs.
My expectation is that the Optinose device would be single use closed system with a single dose of sumatriptan inside and not accessible. If this is the case you'd throw it away and use a new one for the next dose. For $40-50 they can certainly afford the plastic and, more importantly, that would prevent a migraineur from crushing an oral sumatriptan tablet and using it in the device. I really don't know if that would be possible - maybe the formulation is too different to allow adequate absorption for example. However, if it is possible I wouldn't be surprised to see patients finding a way to "reload". Might be a good question to pose directly to AVNR if anyone gets the chance.
"They still could have gotten FDA approval with a non-inferiority study." I'm not at all convinced this is the case. They didn't have to get sumatriptan approved, they had to get sumatriptan via a new delivery device approved. A comparison group using a different delivery system would introduce additional variables and likely would not have been accepted. In addition, I don't think they gain much/anything with non-inferiority...in fact, it would likely be purposefully misused by the other nasals as "no statistical difference" when it was not powered to show a statistical difference.
I don't have numbers for a power analysis but the numbers climb very rapidly with active comparators. For example, they would probably target the 30 minute time because Onose gets in faster. In the trial done, there wasn't even a statistically significant difference at that time vs. placebo (though the trend was very obvious at 15 minutes) so they would have to do multiples of the patients tested for superiority. If someone here is able to do a back of the napkin type of power analysis I'll look up the approximate numbers for expected differences in effects.
gerund or present participle: canoodling
kiss and cuddle amorously.
"she was caught canoodling with her boyfriend"
Hi RBR...I think we have different ideas about what canoodling means. Either that or AVNR has pathologically distracted you!
These studies cost many millions. I think you misread and misunderstood. I said "cost of the medication" is not a factor.
Optinose's non-inferiority is patently obvious. If they want to prove superiority vs an active comparator then it will need to be powered several-fold vs. placebo studies. Power = $$$$
I don't think I've ever heard of a study where the cost of the medication is a consideration. There are probably some but not in this case.
I'm sure Optinose took the most economical and direct route to preparing their FDA package. If AVNR had controlled the process I'm sure they would have done the same thing as neither has any cash to spare. In addition, even if they had the cash I doubt a non-inferiority would have been an acceptable alternative as they were really evaluating the delivery system and not the generic/approved drug.
There is a general feeling among headache treaters that "all triptans" are the same. So at some point, when AVNR is far more financially secure they might run an extra study. At that point of course it would not be non-inferiority but instead something like pain relief %'s at 15, 30, 45, and 60 minutes with 30 min being the primary endpoint. I think they could show a statistically significant difference pretty easily but I wouldn't expect to see this study any time soon
You may be using the more accurate monthly numbers, we may be using different ways to fit the weekly data into the Q's, or I may have some mis-entries. I also noticed that the total dispensed for last Q was higher than either of our numbers. Your numbers seem to match BW's so if there's an error it's more likely to be mine.
With the numbers anywhere in this range I think we'll all agree we were hoping for a faster rise.
Based on weekly pills sold there was a ~2.5% increase this Q vs. Q1.
There was a N price increase midway through Q1 so that will help Q2's comparisons.
Hopefully Januvia revenues will increase but that is likely to be more than offset by the seasonal decrease in Abreva royalties.
For next quarter (Q3) we will have total drop out of Abreva and Januvia growth is likely to have flattened substantially. If they want to increase revs they'll need to do it with N.
Thanks Chico. A few others that may be of interest:
[P5.341] Study Of Pseudobulbar Affect Symptoms In Veterans With Mild Traumatic Brain Injury
[S26.003] Impaired Cortico-Ponto-Cerebellar Networks Underlie Pseudobulbar Affect In Motor Neuron Disorders
[S36.002] Prevalence, Course And Associations Of Depression In ALS: Lack Of Worsening With Disease Progression. Excerpt: "CONCLUSIONS: Depression is prevalent in ALS...ALS patients who are female, older, have pseudobulbar affect, or respiratory onset of symptoms are more prone to depression"
[S36.001] ALS-Plus Syndrome: Non-motor Features in a Large ALS Cohort
"Patients within the ALS-plus phenotype were associated with...increased prevalence of pseudobulbar affect (49.3% vs 25.1%)"
[P5.082] Telemedicine in the Home for Veterans with Amyotrophic Lateral Sclerosis "Results: Enrolled veterans have had improved ALS care, including discontinuing riluzole with tracheostomy, treatment of pseudobulbar affect..."
I don't expect Onose to be faster than injected so for this measure Onose might be faster than the other nasal products by 1-3 minutes. However, this is not the measure that is important.
The most common measure is when headaches go from severe to mild or absent. That is usually given as % at time points from 30 min to 2 hours and that is what patients want to know....How long til I get relief? Onose seems to be substantially better and the PK data for it provides a very clear explanation as to why we'd expect it to be better.
"Fear" levels occur along a continuum. Willingness to wait for response occur along a continuum. Somewhere in the intersection of those continuums (not sure on the plural here) is Onose's theft of a portion of the injected market.
I don't think focus on "onset of action" is legit but if you want to argue onose can't beat nasal's 15 minute mark by more than 3 minutes then you'll have to accept that injection won't beat it by much more.
Injected is absorbed almost instantly in a big bolus...hence the big Tmax and early AUC advantage. All this PK stuff doesn't hold a candle to actual efficacy though.
Hi Ray...Optinose is different than other intranasal. If you look at a study by Rothrock (Headache 2013; 53; S2:21-33) you'll see that Table 2 shows:
Tmax (minutes): injected 12, oral 210, intranasal 60-90, transderm 66, and Onose 20
Cmax (ng/mL): injected 72, oral 18-51, intranasal 5-16, transderm 22, and Onose 11-16
More important than the PK data is the response data IMO. Here's the segment at 30 min:
OptiNose system 16mg....42% "pain relief" at 30 minutes (OptiNose reported)
sumatriptan nasal spray 20mg...28% "initial headache response" at 30 min (prescribing info)
Zomig (zolmitriptan) nasal spray 5mg...~32% at 30 min, ~60% at 1 hour (prescribing monograph)
Sumatriptan injection 6mg...63% "migraine relief" at 30 min, 73% at 60 min (prescribing information)
Zomig orally disintegrating...~23% at 30 min (prescribing information)
If they want to take share from the oral market they need to overcome the cost barrier which is a bigger hurdle.
Overall, I don't have a sense of acceptance but of forced to GUESS I'd say the pros will outweigh the con just enough to get to AVNR’s projections of revenues…years down the line.