Done Deal

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Anonymous

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It is over. You can...
continue to wallow in your sorrow that the FDA made the wrong decision
OR
continue to complain about how the recruiters passed your over
OR
continue to believe the RBD's had already hand picked their team
OR
get over it!!!!
 












Anonymous said:
I vote for , the FDA made the wrong decision!!
Click to expand...

Northera data is truly suspect at best in its current form ... No durability of effect, questionable long term safety. Throw in generic competition, too many reps, and a clueless management team and you have a company that has failure to launch.

This will take more than a year before any further FDA decision ... And more than likely, longer than that. FDA will not be priority reviewing this drug whem Chelsea finally gets their act together, if they ever do.
 






Northera data = what the FDA required in the SPA for approval. FDA broke the SPA contract. They did not design the trials to show durability of effect based on the FDA guidance. Long term safety data is not questionable. Midodrine is hardly competition. They will get a priority review -- it is an orphan drug.
 






Anonymous said:
Northera data = what the FDA required in the SPA for approval. FDA broke the SPA contract. They did not design the trials to show durability of effect based on the FDA guidance. Long term safety data is not questionable. Midodrine is hardly competition. They will get a priority review -- it is an orphan drug.
Click to expand...

Wow ... you truly are brainwashed. Let it go. A SPA (Special Protocol Assessment) is merely an agreement with the FDA that the trials would be sufficient for filing if endpoints are met. What you fail to realize is that when the FDA analyzed the results of the trials, durability of effect came into question because it was shown in the clinical data. The FDA did NOT break the SPA contract. Long term safety is in fact questionable based on the Japanese experience ... and the fact that there is not long term safety is a North American population as well. Lastly, orphan drug designation does not necessitate priority review ... I can cite plenty of recent examples (see Aegerion and Genzyme's filing for familial homozygous hypercholesterolemia). Let it go ... if you're still hoping that CHTP is you're out, you are on hold for a looong time. Stop defending a Company that never had its act together in the first place.
 






Anonymous said:
Northera data = what the FDA required in the SPA for approval. FDA broke the SPA contract. They did not design the trials to show durability of effect based on the FDA guidance. Long term safety data is not questionable. Midodrine is hardly competition. They will get a priority review -- it is an orphan drug.
Click to expand...

HAHAHAHAHHA You guys are Fucked. No APPROVAL-Now What?? What a Joke-people actually took this job and on first drug they got the AX
 






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