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Re: Approvable Letter from FDA on Jan 16th      8-Nov-09 12:01 pm    
I think November..but thats me..
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Statistically speaking, around 50% of NDAs get full FDA...
mnkd.millio... 7-Nov-09 12:24 pm  
 
Very well put. Don't count on FDA delivering anyth...
jolly_ranch... (2 Ratings) 7-Nov-09 12:45 pm  
 
I agree. If anything, FDA may request Risk E...
smr1907 7-Nov-09 12:57 pm  
 
A proposed REMS has already been submitt...
rtcpl35 7-Nov-09 02:57 pm  
 
FDA might have misplaced the REMS i...
na_baaba_na 8-Nov-09 07:38 pm  
 
Don't forget the FDA also gives priority to d...
ddbikessams... 7-Nov-09 01:41 pm  
 
I'm not sure what type of priority you'r...
jolly_ranch... 7-Nov-09 02:34 pm  
 
The FDA may have denied priority re...
ddbikessams... 7-Nov-09 05:00 pm  
 
National Health Care bill..I c...
itellthefut... (1 Rating) 7-Nov-09 05:08 pm  
 
...
itellthefut... (1 Rating) 7-Nov-09 06:10 pm  
 
I hope you are right---since the damn ja...
wolvesandwa... 7-Nov-09 09:58 pm  
 
FDA no longer provide approvable letters. You are ...
the007doc 7-Nov-09 02:10 pm  
 
They don't do "approvable" anymore. No it is calle...
biopharmado... 7-Nov-09 02:30 pm  
 
Complete Response Letter (CRL) replaces the old "a...
cthamlet 7-Nov-09 04:58 pm  
 
The Complete response letter is for an insuff...
itellthefut... (1 Rating) 7-Nov-09 05:03 pm  
 
You are correct, the CRL replaced the "a...
cthamlet (2 Ratings) 7-Nov-09 06:42 pm  
 
"You are correct, the CRL replaced ...
daviscupper (1 Rating) 7-Nov-09 07:42 pm  
 
Well Dave..maybe National Heal...
itellthefut... (1 Rating) 7-Nov-09 07:58 pm  
 
Point conceded. Still, in the ...
cthamlet (2 Ratings) 7-Nov-09 08:25 pm  
 
1874 The Republican Part...
itellthefut... (1 Rating) 7-Nov-09 08:32 pm  
 
That is exactly the way I...
daviscupper (1 Rating) 7-Nov-09 08:34 pm  
 
I'm still waiting for ANY...
ddbikessams... 7-Nov-09 11:09 pm  
 
The reason you're st...
TheWizard_o... (2 Ratings) 8-Nov-09 11:43 am  
 
IMO...Afresa wi...
risingfastb... (2 Ratings) 8-Nov-09 11:46 am  
 
Re: Approvable Letter from FDA on Jan...
itellthefut... (1 Rating) 8-Nov-09 12:01 pm  
 
Dave, I think Al has more supr...
itellthefut... (1 Rating) 7-Nov-09 08:28 pm  
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