AVADEL

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anonymous said:
Have all positions been filled? Why are there new postings on linkedin?
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I think they are trying to get “back up” resumes in case people back out before drug approval. My question is, how has the FDA gone this long without approving or denying this? It’s WAY beyond the 90 day extension. Has anyone heard anything?
 








anonymous said:
How many generic forms of xyrem are going to be on the market? Or how many different companies selling
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It really wont matter after Jazz and several other companies launch their medical cannabis products. Legal marijuana will soon take over the entire sleep and wakefulness market once the scientists clan up the CBD properties for clinical usage.
 




















































There is a lot of BS out there with regards to the orphan designation.

The regulations are clear. For Avadel to break the Xyrem's Orphan Drug Exclusivity, they need robust evidence that they are either more efficacious, safer or a significant contribution to patient care.

Avadel's problem (similar to other companies in the same situation) is that it lacks a head-2-head vs. Xyrem which they could use to show that FT218 is either more efficacious, safer or better for patients. The FDA decision is going to be base on DATA.

Currently what Avadel has data (granted, good solid data) on FT218 alone - no Head-2-Head study
They are making the assumption that narcolepsy patients will prefer to take only a dose at bedtime and not awoken on the middle of the night to take the additional dose of Xyrem.

Keep in mind that Jazz's Xyrem contribution to patient care is the significant reduction of the oxybate formulation Sodium content - aligning with Sodium intake recommendations on cardiovascular risk factors

A Smart company will have negotiated with the FDA what that Head-2-Head should look like for Avadel to break the Orphan, taking in consideration blinding issues.

Perhaps someone from Avadel can tell us what is their take on the ODE - and be specific on how the data shows that they are a major contribution to patient care.
 




anonymous said:
That's funny and what a small world. I recently spoke with a rep that literally said they were about to walk away from the industry after working for her. Micro manager with a workaholic nasty personality.
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interviewing with her right now. Can you give a little more feedback on her? Shes saying not a micro-manager at all?
 




I don’t know who your talking about but I’ve learned from previous managers that if they are stating they are not micro managers they usually are. Especially if they bring it up makes me think they have been told they are before many times I see red flag
 




anonymous said:
interviewing with her right now. Can you give a little more feedback on her? Shes saying not a micro-manager at all?
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You have to ask what are the chances their drug will get the Orphan and be fully approved by the FDA - and to explain to you the WHY they think so. Lots of smoke and mirrors, but nothing of substance. If it is not approved or the FDA asks for head-to-head studies vs. Jazz's Xyrem, you are looking at a 3 year delay; and you will be let go and no job.

Tell us how it goes.
 




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