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HattieTheWitch

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HattieTheWitch

Re: DewDiligence post# 107802

Tuesday, 11/02/2010 11:46:56 AM

Tuesday, November 02, 2010 11:46:56 AM

Post# of 252398

Marth claims the ANDA is now at the FDA’s Office of Biotechnology Products...to assess immunogenicity, and he implies that this means the drug has achieved sameness to branded Lovenox...


A couple of quibbles if I may...

Marth evidently mangled the name of the section because he said OPB, not OBP.

Also, he didn't state that the meeting with OPB meant that they had established sameness (unless OPB is "management"), he made the mention of establishing sameness prior to his mention of OPB.

See my post 107820 for a link to the audio (@ 57:05).

I hope you can untangle the matter!
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