Sarilumab approval delayed?

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anonymous said:
http://www.bizjournals.com/boston/b...e-delayed-for-sanofi-genzyme-s.html?ana=yahoo

How does this effect the launch? Any word on how long it will be delayed?
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There are multiple reasons FDA approvals may be delayed. Two main types are, first, delays due to data deficiency / safety/ efficacy and the second is manufacturing deficiencies. The first type usually takes longer to correct since new clinical and/or stability data may be required. Given this is a manufacturing deficiency at Sanofi Le Trait, France it is a "short term" delay.

By short term, it means whatever time it takes to correct all the deficiencies captured in FDA's Form 483 during their last audit. Depending on the complexity of the issues, it may take up to 2 years to completely satisfactorily address all of FDA's concerns. Sometimes it may be shorter (6 months) and there's also a chance it may never be addressed.
 
























anonymous said:
There are multiple reasons FDA approvals may be delayed. Two main types are, first, delays due to data deficiency / safety/ efficacy and the second is manufacturing deficiencies. The first type usually takes longer to correct since new clinical and/or stability data may be required. Given this is a manufacturing deficiency at Sanofi Le Trait, France it is a "short term" delay.

By short term, it means whatever time it takes to correct all the deficiencies captured in FDA's Form 483 during their last audit. Depending on the complexity of the issues, it may take up to 2 years to completely satisfactorily address all of FDA's concerns. Sometimes it may be shorter (6 months) and there's also a chance it may never be addressed.
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Since we are talking about remediation of Sanofi's incompetence allied with Regeneron's hubris, this is a symptom of terminal failure.
 


















My original post centered on Sarilumab issues with the FDA.
Now there seems to be drift in scope , so here I go.
Successful organizations require forward thinking, planning, competence (aka, direct experience in all roles except entry level) and above all, ACCOUNTABILITY.

REGN financials indicate healthy cash flow, improved operations and growth/ CAPEX. Given the cited manufacturing issues with "fill and finish" at Sanofi, it makes sense to invest more to vertically integrate REGN operations.

Keep in mind Payor transactions focus on finished product, not drug substance. It also appears Regeneron holds no capacity to further process DS and hence the problem. A RCA is required and may indicate REGN leaders ability for forethought, competence, planning and hubris. Only time will reveal ACCOUNTABILITY.

Sanofi just came out ahead (reduced risk ) in this deal due to other DP franchises that fund their growth.

Btw, terminal failure is by no means redundant as perpetual success will be.
 






anonymous said:
My original post centered on Sarilumab issues with the FDA.
Now there seems to be drift in scope , so here I go.
Successful organizations require forward thinking, planning, competence (aka, direct experience in all roles except entry level) and above all, ACCOUNTABILITY.

REGN financials indicate healthy cash flow, improved operations and growth/ CAPEX. Given the cited manufacturing issues with "fill and finish" at Sanofi, it makes sense to invest more to vertically integrate REGN operations.

Keep in mind Payor transactions focus on finished product, not drug substance. It also appears Regeneron holds no capacity to further process DS and hence the problem. A RCA is required and may indicate REGN leaders ability for forethought, competence, planning and hubris. Only time will reveal ACCOUNTABILITY.

Sanofi just came out ahead (reduced risk ) in this deal due to other DP franchises that fund their growth.

Btw, terminal failure is by no means redundant as perpetual success will be.
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Btw, what kind of porn were you watching when you wrote this? Girl on girl perhaps? No? Ok, where you watching chicks with dicks 14? Also, were you accountable to your left or right hand during said porn? Please tell us as everyone at REGN wants to know. However, sanofi is French and they do not care for porn.
 






anonymous said:
Btw, what kind of porn were you watching when you wrote this? Girl on girl perhaps? No? Ok, where you watching chicks with dicks 14? Also, were you accountable to your left or right hand during said porn? Please tell us as everyone at REGN wants to know. However, sanofi is French and they do not care for porn.
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Ladies and gentlemen, please observe exhibit one of hubris and incompetence.
 




































Sarilumab and we can now set up happy hour to welcome Dupilumab to the failure to launch club (potentially)!

http://seekingalpha.com/news/322675...-launch-due-sanofi-manufacturing-deficiencies

Hey, I'm SOOOOOOO glad the entire REGN is watching / listening Mr. Porn REF. You've been quiet recently.

Just wanted to let you know you're defending easily a $1 billion+ mistake. Yes, that's one BILLION you incompetent, hubris ridden FOOL!

ACCOUNTABILITY NOW!
 












DVP is responsible for multiple manufacturing failures but will never be held accountable as Len leaves him to run his own dictatorship. Another failure to launch. Is the board asleep at the wheel or do shareholders have the most overpaid yes men ever assembled in corporate history?
 






anonymous said:
DVP is responsible for multiple manufacturing failures but will never be held accountable as Len leaves him to run his own dictatorship. Another failure to launch. Is the board asleep at the wheel or do shareholders have the most overpaid yes men ever assembled in corporate history?
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At least Regeneron enjoy (ed) Eyelea's success. Thank you Bayer for all your leadership, planning, action, and above all, ACCOUNTABILITY.
 






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