This is the part of the transcript that most interested me:
<<<Owen Gibbs – Rabbass
I just want to clarify that you believe that you would have not got approval for your generic enoxparain on the basis that you’ve are going to be able characterize say, 80% as opposed to 100% of Lovenox.
Craig Wheeler
Well, I think that is our definite belief. And I think if you look at those approach that the FDA is taking, where they are actually requiring validation because they are looking at overlapping and I thought of a message. If you only had 80% when you started using overlapping methods you would actually show differences. So you really do need to actually have the complete and thorough characterization to be able to meet the criteria you're looking across difference dimensions.>>>
And of course Sanofi said it was not possible to characterize the molecule sufficient to reproduce it, but given that I have not heard anything from Wheeler to convince me that he is not a straight-shooter, and this is a comment that he really means, from what I have garnered over the past year or two, which is probably nothing more than the conclusion that most on this board have reached as well, is that Teva has not characterized the molecule, and at best perhaps 80% of it. I draw this conclusion because Teva keeps emphasizing that it has identified the key components. Teva never states that it has fully characterized the molecule or created its fully characterized equivalence.
Teva talks in terms of historic generic formulations, and not in terms that MNTA speaks of that involve complete characterization.
If this holds...well, it is a good thing for shareholders lets just say (with understatment).
Tinker
btw/ There has been some inquiry of valuation ranges. Dew and others have put forward very good upside valuation ranges, particularly on a single generic approval. I've run the numbers on multiple scenarios and surprisingly I have found that the Deutsche Bank numbers posted in message #100269 were almost identical to the numbers I derived independently.
$15-$20 Teva and MNTA generic approved, $64 single generic, I did not calculate the branded generic along side sole generic as that scenario presently does not seem likely.
On the low range, take $18 as the median (with plenty of future upside possible with Copaxone, M118, FoB, etc., that would be less than a 20% downside from here (ignoring the small, but still possible result of a catastrophic court ruling).
Anyways, those are my thoughts on the primary issues that I think concern most of us presently with MNTA shares.
Look forward to Dew's numbers and thoughts as well as others.
AI
