Replies to post #113247 on Biotech Values

[DragonBits]

dew, there is preasure on MNTA stock price, how does that affect the company?

[dewophile]

Teva characterized the FDA-cited deficiencies in its Lovenox ANDA as “minor"

actually teva did not characterize the deficiencies as minor. they stated that the letter they received is called a minor deficiency letter.

here is the PR again:


Teva Pharmaceutical Industries Ltd announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s abbreviated new drug application (ANDA) for generic Lovenox® (enoxaparin sodium) injection. The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the ANDA including the Company's responses to key questions during the review process. [this was added imo to imply that the "key" questions were reviewed and what is left is not as material
all in all a clever PR

[jq1234]

While we are on the same page regarding the point that FDA now officially required TEVA for more work after submitting similar "minor" ammendment to ANDA as MNTA in 2007, I don't completely agree with your conjecture.

I am not sure TEVA asked FDA for official letter. I believe it is in the interest of FDA to give Teva official response to their ANDA due to Amphastar lawsuit against FDA regarding the alleged conflict of interest. Now FDA can say we approved MNTA's, and requested additional information from Teva. Teva is simply using this to its advantage. We'll know how quickly Teva can respond to this "minor" deficiency. It didn't give timeline in the PR, but will have to answer during CC in the future.