Replies to post #114074 on Biotech Values

[10nisman]

So you're implying that TEVA really did think that approval was imminent?

Don't believe what one says as being what one thinks. IMO, Teva was just trying to hurt uptake in mL.

10nis

[sodrock]

MNTA-

By no means am I an expert and I am using using the factual information that I have at my disposal; but still VERY limited.

HPG sent out a communication, July 23rd, the guts of that email below in Italic. Shortly after this announcement they signed a sole source contract with SNY. So it does appear TEVA was very confident about approval. If they were so confident about approval telling GPO's to stay the course until T-enox was approved; what was in the FDA response and why aren't they shouting from the rooftops about how "minor" these deficiencies are?

Read the email below and you be the judge.

Email sent on July 23rd - day of M-enox approval

We have been in close communication with Teva today, who has been having meetings with the FDA regarding the status of its agent. We continue to have open dialogue with Teva regarding its approval status, and will keep the you and the membership informed of any developments as they arise. In the meantime, please provide any feedback or questions you have regarding this issue.
As a reminder, we have been working with Teva to ensure that all education materials will be available to member facilities for patients upon discharge. In addition, we have worked with Teva in developing a member announcement and a Frequently Asked Questions (FAQ) document concerning the generic version of this product.