Biotech Values

[dewophile]

Bill Marth, CEO of Teva North America, said the company held a meeting with the FDA over its generic Lovenox product and proved that Teva's version is identical to the original developed by Sanofi-Avenis and does not copy the Momenta method

at the quarterly cc teva was very careful to use the term "chemical sameness" which actually is mentioned verbatim in criteria (1) of the 5 criteria necessary to meet FDA standards to market a generic lovenox. the fact the term "identical" is now ascribed to bill marth is more concerining imo. in light of the lawsuit he also states the FDA said thier version "does not copy the momenta method". i find it hard to believe they got a meeting in the 2 days between the filing of the lawsuit and the end of the workweek. so if the FDA said the method does not copy momenta's at the last meeting (in october) then why not mention that at the cc in light of mnta's recently issued patents? and why not mention the term "identical" rather than the carefully worded "chemical sameness" at a public forum like the quarterly cc? my hunch is that the reporter must have gotten some details confused. i think bill marth and not the FDA feels their method does not copy momenta's (in fact would the FDA in fact get into the middle of a potential infringement issue before a lawsuit was even filed and explicitly state this?). also if they were :identical" in october (or even since) then why don't they have approval? there should be nothing holding them up (after all we know "they got inspected" already). or is the reporter casually using the term "identical" in the piece instead of "chemical sameness" which is an awkward term for the lay public (after all no quotation marks were used in the article to cite what marth told the reporter)
i'm rambling here and just don't know - but if someone (hello genisi) was able to get a hold of the reporter and corroborate that bill marth in fact said the FDA confirmed the products are "identical" and also "dont copy momenta" (as alluded to in the piece) i for one would be concerned about a near-term approval. but the way this is leaked - with no verbatim verbiage ascribed to marth - teva has deniability if necesasry to defend accusations of fraud by investors (i.e. i think they are misleading investors but not crossing the line legally)
so in short my guess is teva can in fact meet the first criteria of "chemical sameness" using a non-proprietary methong of MNTA's, and that is it