Riva get approval for a fib?

OMG please don't tell me that we that we willot get approval now...and I just quit my prior job. I feel like a fool...why do they hire sales forces before a drug isn't approved...doesn't make any sense these days to do that. What wil become of all the reps if there isn't approval?

 

A VERY short severance and a VERY long unemployment line. You were sold, and bought, a line of shit.

 

You are so right. The future doesn't look bright here. Even if there is eventual approval, Riva will never be looked upon positively versus some of the other competitive products.

 

Wow! You started your own thread and were ambitious enough to respond to yourself twice in an hour and a half! Bravo! Your brilliance is seen everywhere, you should sign your name and give us all your email address so we can personally congratulate you on your achievement! Bravo again! Stupid douche.

 

Whoever posted, they are RIGHT and you sound upset and demoralized

 

I don't know if they got approval but it is "a fib" to say it has...

 

If you have a job-don't fall for the dm's/rd's bs about how it's going to get approved & quit to come here. As for the first post, "why do they hire before a drug is approved?"-the question remains - why do you accept before the drug is approved? Muhahahaha

 

FDA says yes, by a 9-2 vote, for afib indication.

 

The 9-2 vote is for a modest indication. Not first line until further studies are done so quit posting half the info. You dimwit with half a brain

 

It's all how you look at it. This is better than yesterday's hype.

 

The vote was for approval of the indication. There was discussion about having a post-marketing study to determine if a transition protocol to warfarin needs to be established. There were also opinions regarding when to use but no request to have the labeling state first, second or third line. If I have half a brain you clearly have far less than that. Go fuck yourself.

 

Now, now, now brown cow. You sound so big and tough on here with your language but your face is probably brown from all the booty licking you do and never having the balls to do anything but that. We all know who you are. You raise your hand to comment on everything at a meeting and to find you we only need your boss to bend over. So the panel didn't specifically say first, second, third line but dr after pradaxa and warfarin fail will you use xarelto

 

Hey puss, you threw out the first insult, don't be so weak when someone responds back in the same manner. And, just for you, suck my balls.

 

That's an easy one moron...sometimes you NEED a job to support your family and you have to act like the job is the greatest Muhahahahaha

 

Everyone is going to quickly defend Riva as they don't want to realize this was a huge mistake. Take a strong look at the data and compare it to others...BMS will more than likely be the market leader. This will not be a fun area of medicine to be in considering the market is now saturated with products...including generics. If patients are doing fine on warfarin...they will stay on it. It will be extremely difficult to get first line option

 

XARELTO Advisory Committee Follow-up September 9, 2011, 10:06 am
Yesterday, the FDA’s Advisory Committee voted 9-2 in favor for recommending approval for XARELTO. This is a remarkable outcome considering the very negative Briefing Document released by the FDA in advance of the meeting. Let me rephrase that, it was not just a very negative Briefing Document but probably the most negative Briefing Document I’ve ever seen. The J&J (JNJ 63.70 ↓-1.93%) team must be congratulated.

But, how could the FDA interpretation of the data be so different from that of the sponsor, their advisors and the Advisory Committee members? With such a positive vote by the Advisory Committee and such a negative review by the FDA, somebody seems to have gotten it very wrong. At the 4,000 ft level, there appears to be a clue. The overtone of the FDA review can be seen to have the flavor of “in a perfect world” while the contrary view of the sponsor and their experts emphasizes the “real world” experience of treating these patients. Does this sound familiar? To me it sounds like the same debate the 535 perfect-worlders in the principality of the US Congress are having with the real-worlders who elected them.

The approval of XARELTO for this indication is ultimately still in the hands of the FDA and they will make their decision on their view of the benefit/risk of this product and the ability of the sponsor to provide adequate labeling for its safe and effective use.

 

keep n mind that this was the advisory board that recommended the FDA approve riva. The FDA has NOT weighed in yet and we need to wait until Nov. The FDA doesnotalways follow the advisory boards advice...so we shall see in about 2 months

 

I'm just glad to hear you think you have some balls....it's mind over matter, so keep up the good work.

 

You obviously lack in reading skills so I can only imagine how well your listening skills are but let's see if we can't try this one more time since you so thought you got it right.
"as for your first post", I just left a prior job to come here, I feel like a fool. Why do companies hire before a drug is approved?
Because YOU have set the standards so low, they don't care who they get....MORON (I mean...Muhahahhahhaha)

 

Are you that much of an idiot?! Why the he'll would you assume I was the original poster? I was just responding to a dumbass post by you like a lot of people do. You are such a moron!!!