Anesthesia Update

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Sugga will never see the light of day. Not a chance.

Merck is paying the price for its sins. You shouldn't lie to the FDA...or your patients...or your employees. If I were at the FDA, I'd be punishing us, too.
 




FDA hands Merck it's ass on a silver platter. very funny. The payback for the Januvia snow job is landing on Merck in spades. Osteoporosis drug first, the sleep agent, now the anesthesia drug.

You go FDA. Clearly Merck is a third tier outfit that somehow thinks it is above FDA policy.

What do you think ? Merck "protected" 1-2 billion of Januvia sales, but just lost itself 3 billion in revenue and further damaged it's rap in the market.

I love it. and of course the field is still being hand cuffed into oblivion by BPC leaving the reps with no resources and/or value to the customer.

Merck leads by example. The board and MRL lie and cheat...and the field is hounded to quit out of exasperation over the absurd small minded policies.
 




Anonymous said:
Good one Jan!! Keep the pressure on us to sell a drug without an approval!!
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Its ok team, keep making those monthly anes/surg calls cause we are watching you!
Remember though, even if we are running the "coming soon sugg" campaign, are getting raped in the press, and not telling you a damn thing, DON'T MENTION SUGG !!
But, your metrics determine bonus and rfm dollars.

Love you all and are SOO Proud of your dedicated efforts!!

Jan
 




Do you think that is all there is, just a few study file irregulaties? Could someone who understands regulatory matters do some educated guessing of what this means, what is the FDA likely to do, how much longer before we get sugga to sell.
 




Sugg delayed into January. We are being told January 2014. I suspect that is a fabrication, Merck has not been informed of any time lines for the site investigation, nor how long that will take. Word is that the other three sites will now be "reviewed". If there are any protocol violations, this could get really ugly.

The FDA hates and distrusts Merck. That mistrust is well deserved. The board of directors should have several heads on a platter. Instead, they do nothing as Merck is handed it's ass, and our stock plummets.

Most importantly, dot your i's and cross your t's, record every call, refrain from meaningful patient and product discussions and of course carry your IPAD/GPS units !!!

Yes, that type of absurd compliance should improve our relationship with the FDA.

What a ____ ing joke.
 




Anonymous said:
Sugg delayed into January. We are being told January 2014. I suspect that is a fabrication, Merck has not been informed of any time lines for the site investigation, nor how long that will take. Word is that the other three sites will now be "reviewed". If there are any protocol violations, this could get really ugly.

The FDA hates and distrusts Merck. That mistrust is well deserved. The board of directors should have several heads on a platter. Instead, they do nothing as Merck is handed it's ass, and our stock plummets.

Most importantly, dot your i's and cross your t's, record every call, refrain from meaningful patient and product discussions and of course carry your IPAD/GPS units !!!

Yes, that type of absurd compliance should improve our relationship with the FDA.

What a ____ ing joke.
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Blame the FDA? I am glad they have a high standard and protect patients!

There are supposedly issues with the sites. And this is yet another drug for which there is almost no need. Succinocholine wears off in five min- and that is used more frequently than roc or vec now anyways. Another product that practitioners dont need or want but merck thinks they know better.
 




Anonymous said:
Blame the FDA? I am glad they have a high standard and protect patients!

There are supposedly issues with the sites. And this is yet another drug for which there is almost no need. Succinocholine wears off in five min- and that is used more frequently than roc or vec now anyways. Another product that practitioners dont need or want but merck thinks they know better.
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Huh? Sux is used more frequently? Where the hell do you live?

I read this crap on CP and realize my co-workers are complete idiots.
 
















Anonymous said:
I am not a co-worker but actually use these medications every day. Just my own experience...
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Hahahahahahaha. sure you do. but based on the incredibly slim chance that you aren't lying, you would be the worst Anesthesiologist or CRNA in the land.

It might be a more modern practice to offer your patients a good bleeding next time you go to work.

Also, the world is not flat.

That being said, sugamadex is a great product that could make everyone's life easier. Merck's marketing strategy is going to be what kills this drug.
 








Anonymous said:
Hahahahahahaha. sure you do. but based on the incredibly slim chance that you aren't lying, you would be the worst Anesthesiologist or CRNA in the land.

It might be a more modern practice to offer your patients a good bleeding next time you go to work.

Also, the world is not flat.

That being said, sugamadex is a great product that could make everyone's life easier. Merck's marketing strategy is going to be what kills this drug.
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if it's a great product why did they need to play with the data and screw things up for the FDA? Will we price it as high as SP priced sugg in Europe? That will be the kiss of death as it is slow go in the EU. Wondering when they will break even on this drug.
 








Anonymous said:
if it's a great product why did they need to play with the data and screw things up for the FDA? Will we price it as high as SP priced sugg in Europe? That will be the kiss of death as it is slow go in the EU. Wondering when they will break even on this drug.
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Pricing and marketing will be what kills this drug. $100 a dose isn't going to attract many takers. I know the folks in marketing think they have developed a strategy that will demonstrate the "value" of this product and overcome the ridiculous price but at the end of the day Merck has shot themselves in the foot by overestimating how much they can gouge the hospitals for.

The data wasn't "played with". They just thoroughly screwed up the data collection and analysis portion. Which is even worse than altering data these days. I've heard of tons of companies altering data. I've never even heard of a company screwing up the data collection and analysis process. For a product that was limping along with a poor marketing strategy and 10 years of delays it has attached such a bad taste that clinicians now think there has to be something wrong with the product.

Basically it just shows how inept Merck is from top to bottom. In 25 years I've never seen a company go from a top notch, respected company to an absolute joke and one that will be fortunate to remain functional over the next few years.
 




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