Replies to post #101625 on Biotech Values

[zipjet]

(note: request for TRO was denied)

I'm not sure of that. If so there should be an order saying so.

The briefs are titled to support or oppose both the TRO and PI.

So it is possible that the TRO was passed to be taken with the PI. In effect, that is comparable to denial of the TRO but is NOT the same.

ij

[mouton29]

Two key authorities --

The most important case cited in these pleadings seems to be the Appeals Court decision in Serono Laboratories v. Shalala. Here is a link to a copy of the case, it is a mere 20 pages or so counting footnotes. http://www.fda.gov/ohrms/dockets/dockets/04p0231/04p-0231-c000001-Exhibit-33-vol4.pdf

The case is cited by both sides on what appears to be the key substantive issue -- whether the FDA could consider or require immunogenicity testing. The key argument by SNY is that the case and law permit the FDA to consider such testing if voluntarily submitted but that the FDA may not require such testing.

The even more basic authority is section 505 itself, available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.92

[go seek]

Expect Teva is watching this lawsuit...

1. I agree the lawsuit is a Hail Mary on SNY's part and has very little chance of success.
2. The lawsuit may in some way shed more light on why Teva was not approved to date.
3. The apparent fact that no inspection of Teva's Lovenox manufacturing facilities has occurred to date speaks volumes as to how close the FDA is in approving the Teva's aNDA.