Replies to post #108450 on Biotech Values

[DewDiligence]

Also critical of the FDA's actions are Momenta's rivals--including Teva Pharmaceutical Industries Ltd…and Amphastar Pharmaceuticals Inc… Teva officials told the [Wall Street] Journal that the company met with the FDA in October and complained about possible bias. It said its application, which was filed two years before Momenta's, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.

So, Teva acknowledges that its Lovenox application is “stuck in bureaucratic limbo.” I already knew this was true, but to hear Teva admit it is music to my ears!

[turtlepower]

This is amazing and confusing at the same time. Why is bill marth publicly being confident while privately complaining about FDA delays? I know I know, shlomo told him to do it but still.

[dink00]

What is this "delayed notice" that TEVA officials refer to? Is it something recent that they received, since FDA haven't finalized the terms for evaluation until recently or the one in 2008 when they were asked for immunogenicity data 1 month later than Momenta?

dink

[10nisman]

MNTA/TEVA

Teva officials told the Journal that the company met with the FDA in October and complained about possible bias. It said its application, which was filed two years before Momenta's, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.

Amphastar filed the first application to make generic Lovenox in 2003. It says the FDA told it in late 2007 that it met the standards for "sameness" but then the standards changed. The company sued the FDA in October, alleging favoritism.

I think this WSJ article puts everything into context. Teva stated on its latest Teva earnings call said that it was told by the FDA that it achieved "sameness". According to Amphastar it was told in late 2007 that it met the standards for "sameness". So IMHO Teva's was just repeating what the FDA stated to them in 2007 before MNTA changed the standards.

10nis

[jq1234]

Here is the link

http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?mod=rss_Health

[DewDiligence]

More journalistic sloppiness: The WSJ article you posted incorrectly states that Lovenox is “a fast-acting form of heparin.” It is no such thing, of course.

[apljack]

MNTA: and FDA work

Can anyone tell us why MNTA did not charge the government, or conversely, why the government didn't pay for the work? Did the govt. offer to pay and MNTA turned them down?

I'm trying to think of a parallel situation. Say the govt needs to find a threat via analysis of huge amounts of internet data and ask IBM, with their Deep Blue computer, to help them with the analysis as they have unique capacity to perform the analysis. IBM certainly has many government contracts also pending with the fed for equipment sales, but complies with the govt's request to help with the threat analysis. Conflict of interest? Appearance of conflict of interest?

Wouldn't it be nice for the fed to address this by sending MNTA a nice check for the work they did?

aj