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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (5417)	1/13/2002 7:08:37 PM
From: Miljenko Zuanic	Read Replies (2) \| Respond to of 52153

<<CRXA and IDPH seem to be decent drugs and mostly a sluggish FDA at this point.>>. Contrary to many opposite views I think that FDA is doing fair and good job, up to their ability and capacity. And the task which is in front of them. Last year AMLN is good example and indicator. So, regards the Zevalin and Bexxar, it is problem in drug combination (mAb + toxic radioactive component) which have problems in manufacturing, storing, handling, dosing, efficacy, … you name it. Both drug are failure because even if they are approved the will not generate financial return which will cover development expense (their own and those few more who failed, every drug which reach market should cover at least expense of two-three more). <<IMCL is poor trial design and/or regulatory screwup by the company.>> Today significant delay is failure, especially if there are two-three close competitive drugs. <<NEOL is unclear on the reason for the delay. NPRO is pretty much on schedule for its Taxol ANDA, so I don't know why it's included in your list.>> Seems that PHA is bit concerned about weekly LEP efficacy, while NPRO 12 months for ANDA (which is long for generic injectable formulation) is now only dream. Problems in manufacturing? Both appear now more like failure than success (from competitive view). <<Let's hope they are friendly enough to agree on a decent and strong FDA Commissioner.>> Luck of Commissioner didn’t stopped FDA lately to discover significant and serious deviation in manufacturing processes at almost all pharma (and probably few bios may follow). Who is one who thinks that cheating is part of business? Point is that Commissioner can do so much, but for long NDA/BLA review time bios/pharmas can be blamed partially as well. Miljenko