Replies to post #101111 on Biotech Values

[DewDiligence]

And yet you still have Teva speculating that since they submitted their data a month after MNTA, that perhaps the delay of obtaining approval is that the FDA has had one last month to review this data. Come on, it is August for crying out loud!. It has been at least 8 months, and 9 months for MNTA. That seems to be about as facetious of reasoning as any I can think of.

Agreed. These kinds of patently silly statements are par for the course for Bill Marth. That’s why I suggested in #msg-45522123 that Marth’s title ought to be changed to Teva’s Minister of Propaganda.

I don’t completely agree, however, that Marth’s comments in #msg-45522123 rule out the possibility that Teva has improved on the drug in the original ANDA filing. Not likely but possible, IMO.

[exwannabe]

Re: MNTA, TEVAs ANDA status

"What I also find bullish here is that Teva is stating in January that their full immunogenicity testing results were submitted no later than January of 2010. And yet you still have Teva speculating that since they submitted their data a month after MNTA, that perhaps the delay of obtaining approval is that the FDA has had one last month to review this data.

Come on, it is August for crying out loud!. It has been at least 8 months, and 9 months for MNTA. That seems to be about as fecetious of reasoning as any I can think of. "

I disagree strongly with you. The argument that it could take the FDA the same 9 months for TEVA that they took for MNTA is certainly somewhat rational.

More importantly, this argument will play very well with the average investor, who has absolutely 0 clue what the FDA was discussing in the reply to the CP.

The good side to this is that it sets a window for when a "soon" decision would be. Once a few months have gone by, TEVA is obviously having issue(s) with the FDA, and that will be obvious to the more casual investors.

So a significant amount of market assigned risk will lift in the next few months. I would expect that around the time of the next Q CC we should see a return to a more reasonable valuation (presuming no bad news or course).

[DewDiligence]

Why Teva won’t get FDA approval for Lovenox:

I recently reread my own post in #msg-45522123 and I see that it has the smoking gun vis-à-vis Teva’s lame attempt to copy Lovenox. Here is the relevant passage, which is a direct quote from Bill Marth at the Goldman Sachs conference on 8-Jan-2010:

“...with Lovenox, the active sequence has been identified by us. It has been identified by the innovators. It has been identified of course by Momenta and Amphastar. So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity.”

Bill, the “other stuff” in Lovenox that you speak of is not necessarily junk; to the contrary, it may have physiological activity that is not well understood.

If you have not characterized the Lovenox junk, then you have not replicated Lovenox and your drug is not the same as Lovenox. That’s why you have not gotten FDA approval even after eight years.

Sorry, Bill—your ItalFarmaco gambit may have been a reasonable thing to do in 2003, but it doesn’t cut it with the FDA and I think you know that already.