Rytary

Thoughts? Anyone have any updates? I got a contingent offer through Inventiv for a position in the west coast and was hoping for an announcement today.

 

I am interviewing next week. What was your contingent offer...can you share? It seems like everything is secretive about salaries etc. Anything you can share would be appreciated.

 

So FDA states January 21st as official approval date. An official offer will follow probably on the 22nd with the 21st being a holiday. I think the managers have been instructed to not give offers till rotary gets approval. Hold tight till the 22nd and call the hiring manager if you don't hear anything.

 

I actually don't have much info, they haven't given any salary info yet. They said offer letters would be sent out once the drug is hopefully approved! Good Luck with your interview

 

So I guess offers wont be going out

 

From what I am reading it sounds like the Heyward plant needs to be re-inspected before FDA gives the approval. Wouldn't they have inspected it before todays date?

 

Darn! Do you think our preliminary offer still stands when rytary gets approved?

 

How long will it take for them to get the plant re-inspected?

 

Why wouldn't the inspection take place before todays decision date? Anyone see where there is a new date of approval? Wonder how many people they will lose now?

 

Let's see if the FDA finished up their tour of Hayward this week. Fingers crossed.

 

It will be at least 3 months from today. An inactive ingredient and manufacturing facility are questionable. The job is pretty questionable...

 

This week? I have a feeling it will take much longer.

 

FDA did not approve, need to re-inspect Hayward plant Recruiter said Inventiv contract cancelled, will take 6-9 months to get to approval point

 

what do you mean Ventiv Health cancelled? no contract? Doesn't seem like Ventiv Health. Most likely this will be a 3 month delay in approval. Or if re-inspection requires more it may take unfortunately up to one year to re-inspect, re-file, paperwork, and FDA gives new approval date behind others on list for approvals.

 

My recruiter never said the contract was cancelled. Just that they will know more details in the next week or two. Rytary is going to be approved, its a matter of time. The FDA doesn't have an issue with the drug but with the generic processing plant in Hayward.

 

The FDA is inspecting the Hayward facility this week. It's for another drug that is actually being produced there. Not sure if the bureaucracy at the FDA will allow this inspection to count for Rytary or if they need to do a separate inspection at a future date. Given the inefficiency in our Federal Government, I would think that the latter will be the case.

 

Won't matter. Complete Response Letter = filing closed. NDA will have to be resubmitted. Probably 9-12 months away.

 

Ah, bureaucracy. Can't live with it, can't live with it.

 

Ah, the beautiful and strange world of anonymous bureaucratic decision makers...

Can't live with 'em, can't live with 'em.

 

From the moment the letter is closed, 6 months. Book it.