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The people who are hanging on to your thin thread, please let it go? FDA (starting 3 years ago) is becoming more and more teranical when it comes to new drug approval. This drug has to go back and conduct additional studies and IF the moon and the stars line up we're talking at best 3 years out till we see Xeralto and it's new afib indication.

When I sold Pristiq we were all waiting for the vasomotor symptoms to emerge. We were told "In 6 months"..here it is almost 4 years later and the FDA is still rejecting the vasomotor indication.
 






I was told there would be hiring in 2 phases sept. 19th and sept. 26th today by q manager, but tahnks to the guy who posted these articles. The drug was approved in July but, now there is additional data needed so it could be delayed for up to two years. The advisory committee will mee this Thursday...so wake up and google Xarelto...that is the best way to know whether we even have a shot of thsi contract...not to be negative but I've been in pharma for awhile and my inkling says know...check out these quotes directly from articles referenced above...tahnks for providing these articles man...i should probably do my research outside cafe pharma...lol

"The wording is quite critical," said Karl-Heinz Scheunemann, an analyst with LBBW. "Should the committee agree with the recommendation - which is not always the case - it's safe to assume that there will be a delay in the market approval."

The FDA will make its final decision after taking into account the views of an advisory panel, which considers Xarelto on Thursday.

Xarelto was approved in July for reducing the risk of deadly blood clots in patients getting knee and hip replacements, a small part of the potential patient pool. That approval followed a delay of roughly two years due to FDA concerns about internal bleeding risk -- a side effect listed on the package insert along with itching, muscle pain, blisters and fainting.

On Thursday, a panel of outside advisers to the FDA is to review data on use of Xarelto in patients with atrial fibrillation, including the staff report and a presentation by the makers. The advisers will then vote whether to recommend that the agency approve it.

They could urge an additional patient study be done, which would cause a long delay before the drugmakers could again seek approval. FDA officials often follow advisers' recommendations, but aren't obligated to do so.

"We now see a first-time approval as being unlikely," Jerffries Research analyst Jeffrey Holford wrote to investors. He noted the staff comments "point to poor clinical trial design."
 






Anonymous said:
The people who are hanging on to your thin thread, please let it go? FDA (starting 3 years ago) is becoming more and more teranical when it comes to new drug approval. This drug has to go back and conduct additional studies and IF the moon and the stars line up we're talking at best 3 years out till we see Xeralto and it's new afib indication.

When I sold Pristiq we were all waiting for the vasomotor symptoms to emerge. We were told "In 6 months"..here it is almost 4 years later and the FDA is still rejecting the vasomotor indication.
Click to expand...

This!

People need to accept that it's a whole new world dealing with the FDA today.

"If" and when this drug every gets an afib indication it will have no bearing on 6517 being dead and gone.

Move along people, nothing to see here.
 






i know the afib is going to get pushed on thurs but thought we all still had a chance...f quintiles i would never do this to potential employees...by the way they are being shady...i would assume some shady shit about to hit the fan...amybe they hire 400, not 200...let's not forget the other three producst...aciphex...nucynta..etc...my gut says no...phucking mother phuckers
 






Anonymous said:
i know the afib is going to get pushed on thurs but thought we all still had a chance...f quintiles i would never do this to potential employees...by the way they are being shady...i would assume some shady shit about to hit the fan...amybe they hire 400, not 200...let's not forget the other three producst...aciphex...nucynta..etc...my gut says no...phucking mother phuckers
Click to expand...

Not the sharpest knife in the drawer are we?

So you think Quintiles is in charge of the FDA?

Afib was going to make up about 90+ of the dollars potentially generated by this company.
Please explain to the rest of us why J&J would want a contract sales force for a product they already have too many warm bodies for?
 






Anonymous said:
i know the afib is going to get pushed on thurs but thought we all still had a chance...f quintiles i would never do this to potential employees...by the way they are being shady...i would assume some shady shit about to hit the fan...amybe they hire 400, not 200...let's not forget the other three producst...aciphex...nucynta..etc...my gut says no...phucking mother phuckers
Click to expand...


You are soo mad you cannot even type straight...I think some territories are still on to help with existing sales force but I have not heard either way except on here...time will tell. I would assume Xarelto is dead for now, but doesnt mean they will not hire a few still. Depends on your territory. This is sad for all of us.
 






Anonymous said:
Not the sharpest knife in the drawer are we?

So you think Quintiles is in charge of the FDA?

Afib was going to make up about 90+ of the dollars potentially generated by this company.
Please explain to the rest of us why J&J would want a contract sales force for a product they already have too many warm bodies for?
Click to expand...

I think insulting people is so immature. People are hurt and disappointed...have some empathy.
 






Anonymous said:
I think insulting people is so immature. People are hurt and disappointed...have some empathy.
Click to expand...

Considering the idiocy of the post the response seemed rather tame.

This crash and burn has NOTHING to do with Quintile or J&J and everything to do with the FDA.

To assert otherwise makes one look like a dumbass.
 












Anonymous said:
Wow! Im just logging in. So I accept the fate of this contract. Are we to assume the reports are our answer? In others, will we get any type of notice from Quintiles?
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They will officially let you know when the time comes.

J&J will announce the deal is dead first and then it will filter down through Quintiles.

J&J will hold out hope that the final FDA ruling might go there way but the initial FDA panel feedback is clear as a bell. This aint happenin'.
 












Anonymous said:
The people who are hanging on to your thin thread, please let it go? FDA (starting 3 years ago) is becoming more and more teranical when it comes to new drug approval. This drug has to go back and conduct additional studies and IF the moon and the stars line up we're talking at best 3 years out till we see Xeralto and it's new afib indication.

When I sold Pristiq we were all waiting for the vasomotor symptoms to emerge. We were told "In 6 months"..here it is almost 4 years later and the FDA is still rejecting the vasomotor indication.
Click to expand...

Tyrannical. And yes, I agree, the FDA is in Risk-Avoidance mode, meaning that drugs approved in 2001 probably couldn't get approved today. (I wish the pharma industry would stop paying the FDA's extortion. Those clowns' jobs would dry up fast without the billions of $$$$$$ Big Pharma pumps into their coffers.)

Even for drugs that are approved reps cannot cite lots of facts in a sales call simply because the FDA makes you prove patently obvious things, e.g. that water is wet (in a huge, expensive, double-blind study) because without that--well--water might be dry...right?

"Congress shall make no law..." but the clowns on the Supreme Court (who work for the gov't) decided that THEY (the gov't) can do any damn thing they want, words on parchment be damned.

Xarelto is probably toast. More importantly, Engine 6517 just threw a rod and all its oil is puddling under the engine compartment.
 






Anonymous said:
They will officially let you know when the time comes.

J&J will announce the deal is dead first and then it will filter down through Quintiles.

J&J will hold out hope that the final FDA ruling might go there way but the initial FDA panel feedback is clear as a bell. This aint happenin'.
Click to expand...

The better question is, What happens to those already working for Quintiles on contract to Janssen who were expecting to transition to 6517?

Is it July all over again (Sorry, you're out of a job. No, you're not out of a job. Actually, you're starting a new two-year contract and will be getting a raise. All of that announced in the span of a two week period...)?
 






Anonymous said:
The better question is, What happens to those already working for Quintiles on contract to Janssen who were expecting to transition to 6517?

Is it July all over again (Sorry, you're out of a job. No, you're not out of a job. Actually, you're starting a new two-year contract and will be getting a raise. All of that announced in the span of a two week period...)?
Click to expand...

I have no idea what the terms of the current J&J contract are.

What you can be sure of is there will be no 6517 contract so it would be a safe bet that you will not "transistion" to something that does not exist.
 


















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