Replies to post #111373 on Biotech Values

[jbog]

10nis,



but that because the mechanism of action of Copaxone® is not fully understood, even a formulation change could impact clinical outcomes.

That doesn't bode well for mnta......

[zipjet]

This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone® can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound.

Ya gotta love their "spin" capacity.

This looks good for MNTA for two reasons. There will not be an alternative-C diluting the C-market. FDA's sensitivity to "sameness" plays to the MNTA advantage.

ij

[marthambles]

So Teva is using the FDA's complete response letter as evidence that MNTA's copaxone can not be approved without clinical trials.

Apparently, the market is buying it.

[jq1234]

This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone® can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound.

Teva is on par with ARNA CEO in spinning nonsense now.

If they turely believed so, why would they submit sNDA in the first place?

[jbog]

This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone® can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound. Teva intends to continue working closely with the FDA to determine the most appropriate next steps regarding the application.

So why did Teva ever submit this application if it knew this? This whole application might be a sham....

[DewDiligence]

Teva’s ‘low-volume’ Copaxone will almost certainly not be brought to market. The subject came up at Teva’s NY luncheon for analysts yesterday and Bill Marth’s reply was that “the future of the program is being debated inside Teva” and that it’s unclear whether the prospects warrant conducting the large safety and efficacy study the FDA demanded as a condition for approval. This is biotech-speak for saying that the program is dead.

[DewDiligence]

Re: ‘Low-volume’ Copaxone

According to Bill Marth on today’s MS webcast, after feedback from the FDA, Teva decided to conduct a new clinical trial for low-volume Copaxone rather than shelving the program. However, insofar as the FDA’s CRL was issued nine months ago and the new trial has not yet started, this program is not exactly on the express track.

For reasons that have been mentioned previously, I consider Teva’s low-volume formulation of Copaxone a gimmick that will not have any commercial consequence for MNTA. Of somewhat greater concern for MNTA is Teva’s thrice-weekly Copaxone program (#msg-63817727).