AVADEL

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anonymous said:
Simply put, your leadership and lack of industry experience sucks. Jazz knows this market and you all don't.
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This might have been true a few years ago, but Jazz abdicated it’s leadership in sleep some time ago. Sleep is no longer their priority.

If Avadel had gotten their shit together in time they would have blown Jazz out of the water.
 




anonymous said:
This might have been true a few years ago, but Jazz abdicated it’s leadership in sleep some time ago. Sleep is no longer their priority.

If Avadel had gotten their shit together in time they would have blown Jazz out of the water.
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And why are you saying that Avadel does not have their SH$T together?
Their data showing the patients preferences to a single night dose are stunning.
 








anonymous said:
And why are you saying that Avadel does not have their SH$T together?
Their data showing the patients preferences to a single night dose are stunning.
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Ok boomer. Avadel nee Flamel has been a dumpster fire since they started the clinical trials that took years longer to enroll than planned just like the current open label trial (moved that completion date out too). Nobody has been storming the castle to get involved in these clinical trials. Adults generally don't like to wet the bed.
 








Fo real? We created ‘novel’ questionnaires’ that no one is going to say no to. This will get us approval, it’s why we didn’t feel the need to ask other questions or even to Ask people who were not paid be in our study.

Are you unaware that a biased questionnaire is all you need to get an approval?


anonymous said:
OMG! Payers LOVE patient preference data cooked up by manufacturers.

this will totally override any NDC blocks or fail first policies.

I’m in!
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Did you guys came out too feisty with that crap about using all internal and external resources against the FDA to get FT218 approved?

It kind of backfired - signaling to everyone else that the talks with the FDA are not going well.

And wassup with not showing the FDA all the recent data on your drug is better than Jazz's? Are you afraid the data ain't that good?
 




















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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