Replies to post #107825 on Biotech Values

[10nisman]

We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets teh FDA's criteria to demonstrate chemical sameness and accordingly that data related to immunogenicity are currently under review at the office of biological products.

The FDA did not confirm Teva's ANDA met the FDA's chemical sameness criteria -- Teva (we) confirmed. Sounds to me like a creatively crafted introduction.

10nis

[HattieTheWitch]

I missed that. Thank you!

For those who want to hear it, Schlomo says what you referred to at about 4:10

http://www.vcall.com/CustomEvent/EU005995/index.asp?ID=162118

Marth does his "uh" and repetitions (sounding dodgy IMHO) at 57:05

[HattieTheWitch]

One can parse a statement to get a favorable or unfavorable interpretation, so I hesitate to bring this up, but...

When Schlomo said "we confirmed that our version of generic lovenox meets the FDA's criteria to demonstrate chemical sameness", why didn't he simply say "the FDA comfirmed that our version of generic lovenox was chemically equivalent to the branded version"?

As an investor, I don't want to interpret something favorably just because it makes me happy, so I thought I'd toss this out there for input.

[ThomasS]

MNTA: "We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets teh FDA's criteria to demonstrate chemical sameness..."

In this case, "we" means Teva. Teva confirmed, not the FDA.


{Edit: I see this was already pointed out. I wonder how many months of "insane profits" MNTA has to garner before investors give them credit?}