Suvorexant FDA Review

[Anonymous]

To me this looks like good news. 10mg dose does not need further studies, just a manufacturing review. See no further problems for approval.

Clearly you missed all of the earlier press releases where Merck had stated that this lower 10 mg dose was not efficacious enough.

 

[Anonymous]

Can today's news possibly get any worse.....Feel bad for those who had worked on this for the last year and a half. Hopefully they were wise enough to have their plan B escape plan ready.

These fools couldn't get a roll of toilet paper approved. They would be asked to do another 2 year study about two ply ae's. We need to clean house in MRL.

 

[Anonymous]

Clearly you missed all of the earlier press releases where Merck had stated that this lower 10 mg dose was not efficacious enough.

Low dose was efficacious you Nimrod
http://www.rttnews.com/2123549/fda-...omnia-drug-suvorexant-but-at-lower-doses.aspx

 

[Anonymous]

Low dose was efficacious you Nimrod
http://www.rttnews.com/2123549/fda-...omnia-drug-suvorexant-but-at-lower-doses.aspx

Afraid not sir:

"In Phase II a 10 mg dose appeared to be safer, raising the possibility that the agency might limit an approval for initial use to that lower dose, even though it wasn't tested in Phase III and Merck officials concluded that the 10 mg dose would not be effective.

The lower dose also has a far lower rate of efficacy, which could severely hamper any future marketing campaign."

Read more: UPDATED: FDA panel backs low-dose rollout of Merck's sleep drug suvorexant - FierceBiotech http://www.fiercebiotech.com

 

[Anonymous]

Another Merck R&D Joke. Peter Kim was the laughing stock of the industry and his spotless legacy of ineptitude continues. When will Merck get a real CEO who knows what they are doing. I hope Roger is cleaning house of all the incompetent Boobs

 

[Anonymous]

Another Merck R&D Joke. Peter Kim was the laughing stock of the industry and his spotless legacy of ineptitude continues. When will Merck get a real CEO who knows what they are doing. I hope Roger is cleaning house of all the incompetent Boobs

Question. So we know there will be a Suva delay regardless. Neuro reps are already being reduced in a few weeks. Anyone know if this is the nail in the coffin for the whole sales team? Do we continue runnin loose with A PI and samples for another year. Credible info please. Was this a SP "fast freddie" drug or another "mother Merck" blunder? Do tell.

 

[Anonymous]

Question. So we know there will be a Suva delay regardless. Neuro reps are already being reduced in a few weeks. Anyone know if this is the nail in the coffin for the whole sales team? Do we continue runnin loose with A PI and samples for another year. Credible info please. Was this a SP "fast freddie" drug or another "mother Merck" blunder? Do tell.

A delay lol? You must be in R and D.

 

[Anonymous]

WTF......seems like nothing goes as planned around here. It's time heads roll.....upper management heads!

 

[Anonymous]

The question is how long is the delay going to be? One month.....Six months.... two years?. The FDA is really sticking it to Merck for the past behavior of their R& D leadership.

 

[Anonymous]

Where's the accountability? Everyone just assumed it would approved? Was there a thought it may not be?

 

[Anonymous]

OK the field force will start training in the summer, followed by product discussions with customers, oops wait...... we need FDA approval of the drug? Really, oh I guess we forgot about that.

 

[Anonymous]

OK the field force will start training in the summer, followed by product discussions with customers, oops wait...... we need FDA approval of the drug? Really, oh I guess we forgot about that.

OMG. Just heard 2 HSC's were fired today. One told Riad to go F himself. The other ripped MT a new one from here to Tuesday. Guess it wasn't safe to speak up. Hot damn. Wish I could have heard that conversation.

 

[Anonymous]

This company is so bassackwards today compared to the 80's. I'm out as of today and so very very thankful.

 

[Anonymous]

The question is how long is the delay going to be? One month.....Six months.... two years?. The FDA is really sticking it to Merck for the past behavior of their R& D leadership.

Delay? Try again. The writing is on the wall. The compound IS DEAD.

 

[Anonymous]

The question is how long is the delay going to be? One month.....Six months.... two years?. The FDA is really sticking it to Merck for the past behavior of their R& D leadership.

Read what the FDA said and the studies. Its done. Over. Merck screwed the pooch on this. Bad.

 

[Anonymous]

Afraid not sir:

"In Phase II a 10 mg dose appeared to be safer, raising the possibility that the agency might limit an approval for initial use to that lower dose, even though it wasn't tested in Phase III and Merck officials concluded that the 10 mg dose would not be effective.

The lower dose also has a far lower rate of efficacy, which could severely hamper any future marketing campaign."

Read more: UPDATED: FDA panel backs low-dose rollout of Merck's sleep drug suvorexant - FierceBiotech http://www.fiercebiotech.com

I stand corrected. Thank you. (I am the Nimrod)

 

[Anonymous]

Could this gang of fools even get a sweet tart approved? Obviously this is typical, bad studies, high dose to cash in, and thank god the agency did the right thing to protect patients.

 

[Anonymous]

Perhaps it is just me, but if one connects the dots of the interactions of Merck with the FDA, one might draw a conclusion that the FDA just flat doesn't trust Merck. And is reluctant to approve based on that uneasiness. And to be fair, Merck doesn't help itself by not addressing its track record of opacity with respect to its filings. Vioxx was the turning point. But the continuing obfuscation of Vytorin while the cash rolls in cannot be helping Merck.

 

[Anonymous]

Perhaps it is just me, but if one connects the dots of the interactions of Merck with the FDA, one might draw a conclusion that the FDA just flat doesn't trust Merck. And is reluctant to approve based on that uneasiness. And to be fair, Merck doesn't help itself by not addressing its track record of opacity with respect to its filings. Vioxx was the turning point. But the continuing obfuscation of Vytorin while the cash rolls in cannot be helping Merck.

It may be safe to say that the FDA trusts Merck less than any other drug company. Period.

 

[Anonymous]

When scientists ran Merck, the confrontations were about data and facts, with confrontations both inside Merck and with competitors and regulators. It was rarely taken personally.

Now that lawyers run Merck, it is about seeing what you can get away with and then establishing the capability to fending off legal action from those you have deceived? And is is now always taken personally in this world of politics.