Momenta Pharmaceuticals, Inc. (MNTA)

[flatlander_60048]

Perhaps NVS provided the notice to Teva that a submital to the ANDA had been made.

I thought Teva and NVS agreed that a 100? day advance notice of a launch would be provided by Sandoz before launching m-copax. Perhaps the major amendment was the bioequivalence study results. This may be a final piece of info that FDA has asked for, hence prompting NVS and MNTA to believe they are close to approval. Perhaps Sandoz informed TEVA that they had submitted this amendment as part of the notice to launch. I believe that any lab data submital maybe considered a major amendment to the ANDA (even if it is bioequivalence and not clinical trial results). I know it may surprise some of you that TEVA could potentially spin this as a positive.

This is just speculation, but perhaps Sandoz wants to provide notice of intent to launch if the final pieces fall into place (FDA approval of what they might believe to be a final piece of information, favorable trial results, etc.).

FL