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Don’t think it moves the needle
It’s just fatty acid so it’s essentially a higher dose. Otherwise no reason MTNB is better other than having high bioavailability
This is rubbish - this would include anyone even with a sniffle which is 10% of patients. They had a protocol for confirming COVID-19 and there was a 95% reduction when following that protocol. Period. There was also a massive reduction in severe cases. Period.
You already have randomized data - who needs a hypothesis generating database study
You could pull together some data but it wouldn’t be meaningful or reliable. It would be impossible to appropriately match the control group with an outcome so uncommon and with huge variability that you’d be comparing noise to noise
Approval is never 100% but there’s 0% chance there’s a CRL due to efficacy. The efficacy is groundbreaking
This is a method patent... based on the fact that it says a method of...
So you’re suggesting there will be a trial due to the GSK ruling?
Not in the US
Except the trial had nothing to do with Reduce It and cardiovascular disease. Why do people still think this?
Huh? They immediately stopped use of the drug and the drug didn’t make outcomes worse. There’s no liability here
You can also compare directly - there is a Trial for Epanova that’s similar to Marine that reports blood EPA levels and they are higher than that for Vascepa both at 4g dose. So epa dose doesn’t explain it.
Actually Epanova is esters so bioavailability is higher and plasma EPA level is the same or higher than Vascepa. So I agree with your point that a lower dose of EPA is probably bad but Epanova doesn’t prove it. Epanova failure has to be a DHA counter-effect
The Hikma label includes afib and bleeding and refers to 8k patient study
Or maybe nobody has drug because nobody thought they’d win the case. It takes many months if not years to even create enough supply to be cost effective to even launch. You can’t make money launching with a few million $$ worth of drug. Nobody was going to invest $10m or more to manufacture a massive lot before the win
You won’t disagree with the offering if something unexpected happens. They can’t risk a major downside for a still small dilution
VOS is 2032 I think. It’s probably a formulation for the eye that’s protected but I’d have to check
LN IP is 2037 but the compound itself is only 2027. So if you add transplant the generics can get a transplant label in 2027 and sell for LN indirectly.
LN should be a big enough indication to grow the company. You wouldn’t add any bolt on a until you really hit cash flow positive. So either you sell the whole thing in next 24 months or weventually use the cash to grow.
There is overlap between the populations. It’s not possible to run a 10k patient trial with Marine label to determine why there is extra afib. Hence why the standard practice is to assume yes and provide a warning. Better to warn inappropriate than not warn
Only 7 years of composition of matter remaining and high price makes additional indications like this extremely unlikely. 2027 is expiration for all but lupus nephritis
It’s not being studied as a treatment for moderate to severe Covid. It’s just as a prophylactic upon Covid diagnosis in a very tiny population.
Just because IL6 is prognostic doesn’t mean blocking it is beneficial. Antibodies against individual ILs have broadly failed.
It is scientifically sound. There was no signal for afib in MARINE because it was only a few hundred patients and severely underpowered for that finding. For safety signals, you need to error on caution. Look at other drugs with safety warnings that are extremely conservative.
You can’t infringe on reduce it with a Lovaza generic
It’s just some additional analyses of same trial data
Not how it works. You can’t get a method of use patent for the use of voclosporin in just any indication that CNIs are already being used. The method of use patent for voclo in LN was based on unexpected results from a unique dosing regimen
Your forgetting composition only has 7 years left. There’s no time to develop any of these indications
He wouldn’t have agreed to a rule 36 if he expected en banc
No they won’t approve 85% pure since they won’t know what the impurities are. You couldn’t even get an INd for an 85% pure API
In defense, it’s unlikely even Amarin would pay for a large Alzheimer’s study with only 7 years of exclusivity remaining
My honest opinion is they won’t take that line of argument seriously with how it’s presented. A more nuanced approach arguing how the improper framing of some of the evidence like Kurbayashi shows you why the secondary considerations are so important to prevent mistakes. This is what Reyna himself argues. Calling it a fraud will make the judges stop reading
The one big thing missing from the Amicus is a clear nexus to the improper weighing of the objective indices, which would have paired nicely with Singer’s brief. Kurbayashi was improperly presented with a cropped table and testimony from Heineken that led Du to wrongly accept the prima facie case as being strongly in favor of obviousness. However, the objective indicia and secondary considerations exist to protect against exactly that - an import per or erroneous assessment of the prima facie. The unexpected results and commercial success should have been a clue for Du that maybe she was understanding something incorrectly - for example, the historical studies did not truly prove what she thought they did. So objective indicia should have saved her. But she discounted it using improper methods of analysis.
They are a generic manufacturer and this ruling effects their broader business - I don’t think they will risk their entire business model for a possible deal to buy Amarin for a lot of money
Did anyone post a copy of the Amicus from the investors on the board?
That’s not safety data it’s efficacy data
Who said aspirin is for covid? He might just be on that already. They just said he’s on it. Rems is fda authorized and there’s at least some data for Regenerons antibody. There’s no basis yet for Vascepa
Existing employees already have option packages. Why would Wall Street hate this? The options are granted at the current stock price so they are only beneficial to employees if the stock price goes up
There is no data for aspirin or Vascepa for covid so how would you convince someone a drug is better based in zero data
GlenMark is not a Teva. It wasn’t 3 months.
There is no direct infringement, only induced infringement. The infringers seems the physician prescribers.