AVADEL

Quote
anonymous said:
As an investor, trying to understand how the company expects the FDA to pass judgement that FT218 is a major contribution to patient care over the approved oxybates formulas that hold ODE, IF they have not shared the most recent data with the FDA? That's what the CEO said in the last Earning Call.
They are making claims to break XYVAW's orphan 7 year exclusivity period, but they haven't given the FDA the data supporting that claim.
Solely to imply that once nightly is better than twice, is just not enough for the FDA.
I bet the FDA's position is going to be: "show me the data!!!".
Avadel is possibly looking at a tentative approval, no launch, and a resubmission.
Perhaps a Launch in the second half of 2024, if they are lucky.

Perhaps smarter people can comment on this post and let us know if the logic is correct or false.
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"Smarter people" on CafePharma? That'd be a first!
 








anonymous said:
Surely their CEO monitors CP.
They all do !

Maybe someone can let's us all know why hasn't Avadel presented the new data to the FDA?
What is there to lose?

Maybe the data sucks.
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New data to evaluate gives the FDA the opportunity to take more time to evaluate. Basically resets the clock by a few months.

the knowledge of any new data gives the FDA the right to ask for the data and reset the clock for approval.

Divis should have made his best case at the beginning. The fact that they were generating new data which would put the approval at risk says they knew their case was week to begin with but they were crossing their fingers.

The agency doesn’t overturn orphan exclusivity easily.
 
















































If you are here. There will be no ‘notice’
If you have an ‘offer’ you will jot hear anything.
The entire leadership team is incompetent to the highest level.
It’s over.
 




anonymous said:
Yes, agreed. I wonder if it also means the whole company dissolves? Market cap of <$100M and does anyone know when the generic for Jazz is out? I read early 2023. If so, how can we get payer coverage?
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Jazz REMS Patent expires late 2023
This allows generics to come in for XYREM (not XYWAV)

FT218 will get a tentative approval.
Avadel still has to demonstrate to the FDA that FT218 is superior to XYWAV which holds the orphan exclusivity for 7 years
Only by doing so, will they be able to get an approval.

2023 is optimistic
Think Late 2024 for a Launch, if and only if, FDA agrees that FT218 is a major contribution to patient care over XYWAV

Good Luck guys!!!!!!!!

:rolleyes:
 




Oppenheimer must have had a lot at stake.

they are crazy if they think there is a market for this product by 2023/24.

generics will take 50-60% and Jazz will hold onto at least 35% via discounts and rebates.

AVDL is done.
 








anonymous said:
Oppenheimer must have had a lot at stake.

they are crazy if they think there is a market for this product by 2023/24.

generics will take 50-60% and Jazz will hold onto at least 35% via discounts and rebates.

AVDL is done.
Click to expand...

Just like LifeSci Capital. Both in the pocket of Deerfield and the larger book of business related to them.
 




anonymous said:
Oppenheimer must have had a lot at stake.

they are crazy if they think there is a market for this product by 2023/24.

generics will take 50-60% and Jazz will hold onto at least 35% via discounts and rebates.

AVDL is done.
Click to expand...

they are crazy and attempting and executing a pump and dump exit plan. this little pig is head is heading to slaughter and off the market. the analysts have to “try” to look credible, but watch them march down the target price as the generics launch. Pennies in 12 months! No buyers for this asset. Payers do not pay for convenience and providers already prescribe a single dose.

the question is “where is leadership and what are they saying”?
 




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