6517

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What makes sense - so it's probably wrong - is that Janssen managers need to get their "chosen one" lists in by this Friday so that HR at Quintiles can get their Azez in gear and make offers by Wed/Thurs.
 












6517 is dead in the water
Information from the fda reports that no additional indication will be grantedfor xarelto. No contract sales force will be hired. Data comes from janssen regional director
 
























Anonymous said:
If a company develops a good drug, they staff-up to commercialize it themselves. Contracting with Quintiles is the sign that the product isn't all that good.
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Bingo! It was a half assed attempt at giving the appearance of getting ready for a launch when it was obvious all along the odds were slim of this getting the AFib indication.
 






From Fiercepharma.com, this is the headline for today...

If you are at all interested in the 6517 contract being confirmed:The FDA dropped a bombshell on the anti-clotting drug Xarelto (rivaroxaban) this morning, noting in an agency review that Bayer ($BAYN) and Johnson & Johnson ($JNJ) had offered insufficient data on safety as well as efficacy for preventing strokes among atrial fibrillation patients, urging an advisory committee to send researchers back to the clinic for another study. In a review peppered with comments that sometimes verged on outright scorn, the FDA reviewer cited numerous reasons for a complete response letter. Just by itself, the potential for unnecessarily endangering patients offered a chilling conclusion for a drug which had been widely billed as a likely blockbuster.

In a matter of minutes shares of Bayer dropped 12%, an enormous bite for a big cap pharma company.
 






Has anyone talked to their Quintiles recruiter or Quintiles hiring manager? This position was going to be responsible for other products besides Xarelto. J & J had to know that they were at risk of no A-fib approval based on their data. If position was based on Xarelto approval, why not wait until after approval to go to the expense of the hiring process.
 






Anonymous said:
why not wait until after approval to go to the expense of the hiring process.
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Because the decision making process is being driven by pharmaceutical marketing people: people not known or possessing a history of realism and rationality. With respect to the other products on the project, the PPI is at the end of it's product life-cycle and has insignificant marketshare, the analgesic product is a non-starter.
 


































































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