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  #1  
Old 02-01-2012, 11:36 AM
Anonymous
 
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Default Where is the Dulera COPD approval...

that we were supposed to get the last week of January 2012?
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  #2  
Old 02-01-2012, 10:18 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
that we were supposed to get the last week of January 2012?
winter freeze.
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  #3  
Old 02-02-2012, 10:48 AM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Just announced today that it was not approved by the FDA. Check Com Central for the full details of the "Approvable Letter."
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  #4  
Old 02-02-2012, 10:48 AM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

It was NOT approved by the FDA.
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  #5  
Old 02-02-2012, 12:38 PM
Anonymous
 
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Banghead Re: Where is the Dulera COPD approval...

For me, this is unforgivable. Between the Singulair threat and the incompetence of our Leadership in most areas of our business. I am done with Merck. WTF were they doing in the studies....this drug is already a grinder and now this. And they keep spinning it, as if were imbeciles.

FU MERCK!!!
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  #6  
Old 02-02-2012, 04:22 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

2nd time in 2 weeks FDA says FU Merck!
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  #7  
Old 02-02-2012, 11:35 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Ok folks.....seriously, what went wrong with our COPD indication? Why wasn't it granted? Any thoughts out there?
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  #8  
Old 02-03-2012, 01:35 AM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Does it really matter? Sales may climb from $14 to $16 annually. Who knows, maybe we'll even get a full prescription some day and sales will skyrocket. Who is the one idiot writing this garbage? That's what I'd like to know.
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  #9  
Old 02-03-2012, 03:33 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
that we were supposed to get the last week of January 2012?
Bahahahahahahahahahahahahaha
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  #10  
Old 02-03-2012, 05:34 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

how about some transparency from the Dulera Marketing Team!!!
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  #11  
Old 02-04-2012, 05:55 AM
Anonymous
 
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Banghead Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
how about some transparency from the Dulera Marketing Team!!!
Really what team??? Those over paid loosers can't manage a Dr. Scholls store in India
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  #12  
Old 02-04-2012, 11:11 AM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
how about some transparency from the Dulera Marketing Team!!!
Schering incurred wrath of FDA and it has carried over. Losers!
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  #13  
Old 02-04-2012, 12:04 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Look the non-steroidal side of the combo is not the FDA's favorite. The steroidal side of the combo was never a big seller. What part of that combo was going to make a blockbuster. S-P knew that this combo was no great shakes. I don't know what Merck was thinking. Over the last 6 years I must tell you that S-P's reputation with the FDA is far better than Merck's. The number of Old Merck's shocking rejections from the FDA is stunning. Half-baked applications from legacy Merck coupled with not particularly interesting products from S-P and the merge company all adds up to some grim days ahead.
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  #14  
Old 02-04-2012, 04:51 PM
Anonymous
 
Posts: n/a
Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
Look the non-steroidal side of the combo is not the FDA's favorite. The steroidal side of the combo was never a big seller. What part of that combo was going to make a blockbuster. S-P knew that this combo was no great shakes. I don't know what Merck was thinking. Over the last 6 years I must tell you that S-P's reputation with the FDA is far better than Merck's. The number of Old Merck's shocking rejections from the FDA is stunning. Half-baked applications from legacy Merck coupled with not particularly interesting products from S-P and the merge company all adds up to some grim days ahead.

It might be better but that is not saying much. SP was on their **** list for quite a while. It was what held up Clarinex for quite a while. The FDA figured- why reward a poor performer by giving them the approval when they couldn't even get Proventil to be problem-free. Merck "merged" with this and now we all will pay the price although Merck pays the higher price because they "bought" SP. SP heads will always have a good laugh about this at Merck's expense.
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  #15  
Old 02-06-2012, 09:14 AM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
It might be better but that is not saying much. SP was on their **** list for quite a while. It was what held up Clarinex for quite a while. The FDA figured- why reward a poor performer by giving them the approval when they couldn't even get Proventil to be problem-free. Merck "merged" with this and now we all will pay the price although Merck pays the higher price because they "bought" SP. SP heads will always have a good laugh about this at Merck's expense.
Bottom line- FDA not happy with us and any form of our company.
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  #16  
Old 02-06-2012, 09:50 AM
Anonymous
 
Posts: n/a
Default Re: Where is the Dulera COPD approval...

Bottom line...the layoff cuts will be even deeper than expected come April. Get ready to bend over.
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  #17  
Old 02-06-2012, 01:18 PM
Anonymous
 
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Default Re: Where is the Dulera COPD approval...

Quote:
Originally Posted by Anonymous View Post
Bottom line- FDA not happy with us and any form of our company.
Ain't coming- BS from marketing
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