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Perhaps, but this runs contrary to what MNTA has been saying. In fact, they've recently started saying the m-copax application only really took off in the last year and a half or so and that the FDA really didn't do much the first 2 years. I think we'll see some sort of resolution before we get the patent appeals in 2nd half 2013.
Got it.
Based on what MNTA has been saying recently I'm going to stupidly go ahead and predict tentative approval before June 2013. :)
Hasn't MYL stated they expect approval in late 2013?
Actually, MNTA hasn't had a chance to protect it's patents because the courts are so far saying safe harbor can be extended into commercial use.
Would the FDA actually respond to it on Saturday or is it a Monday thing at this point?
I dunno go seek. Perhaps though! :)
MNTA is trading close to 10 because they are burning $20-24m a Q and keep losing every legal challenge they attempt. Going forward it will be whether the USSC takes the case and/or if M-copax can get approved. Not sure what the chart has to do with that. Maybe he's right. Maybe he's wrong.
Teckor. Glad to have your TA back on the board. I hope that while you are tooting your own horn, you do recall the 6 months or so you spent here where you couldn't get this stock right to save your life. Either way, nice call on the fall to 10. Have a good one. :)
What exactly do you find useless about them?
to be fair, indigokid brought it to my attention :)
So how does everyone handicap the USSC getting involved?
Hah. This time though, I was talking about "insiders" having knowledge of enox/copax/court cases being the reason the pps is so low. The CAFC overturning a PI from the district court is quite a rare occurrence in itself (especially considering the absurdity of the majority opinion) so one can hardly be blamed for having gone through this roller coaster. And I'm quite aware of our other disagreements on this stock :)
But keep in mind that a majority (2:1) found otherwise. So we cannot have great confidence in making these predictions.
I'd have to believe that there are a lot of insiders somewhere along the way that know whats going on with both copax and enox and the stock price probably reflects their opinion.
Hey Zip,
I take it you don't give MNTA very good odds to have the ridiculous CAFC decision to be reversed?
Management has been very wrong about the future "run-rate"
I commend Baxter for taking a flyer.
MNTA has essentially lost $200m in market cap because of that 34m ($2.5m to MNTA) number for q3. If Rick Shea is accurate about the market (and I've never known MNTA to overstate things), then that # will not be repeated again (assuming no other generic entrant obviously), and will more likely be double that (With 6-8m going to MNTA).
That's my take on it. I only listened to the webcast because I asked IR about his statement from yesterday regarding sales and she said to check out today's for clarification. I'm glad I did listen as I thought today's presentation was better and found the IVG/m402 stuff quite interesting.
Can't they give MNTA a "provisional" approval on the Copax
On the webcast today, Rick Shea clarified the enox economics a bit (even more than yest). He says the market is now "roughly $1b a year range" and that Sandoz has 30% of the market. Sandoz was hit twice in q3 with lowering in-stock prices as well as redoing the deal so he expect the rate to go back to that $1b annualized rate with next Q so would expect sandoz to be in the 60-75m range for Q4.
Appreciate the insight.
Just curious, do you think MNTA will ever attain fully substitutable biogeneric?
$20pps from current prices is till a $500m addition to the current market cap. Folks see Copax a different because there is no validated marker to work with. If/when copax gets approved, I think it will be especially telling on how the FDA will ultimately treat MNTAs program. Regardless, I don't disagree with you about MNTA expanding on the drug rather than going all-in on the generics.
All good points.
My guess is the industry still doesn't think MNTA has the goods. I would imagine a M-Copax approval would go along way in that regard.
c) Management might rethink their incentive pay structure.
Isn't their NCE ruling tomorrow? If so, my guess is the latest RUMR would be a last ditch pump before the no-NCE hatchet comes down.
On the transcript, Shea says the panel is 9, rather than 10...I guess he's just mistaken?
If it goes en banc, I'm taking the liberty of assuming Newman will agree with Rader like he did in Classen.
The notion is Rick Shea's rather than Dew's as asserted on the webcast today
So were at 2-2 then with 6 votes left.
What happens in a tie?
Also, if it goes to en banc I think its safe to assume Newman will side with rader.
Did he say anything further about why the 34m as so low? They didn't really delve into it on the quarterly CC...
DD, anything else of note on the CC. I forgot about so missed it :P
Although Classen is not perfectly on point, it has enough bearing to matter, and I could see the CAFC deciding not to hear this case until the final resolution of that case.
Sandoz: I've heard that Sandoz was especially aggressive in pricing when WPI launched that they were taken a back at the drop in the market. Could this have been a stratagem as far as damages are concerned? If MNTA were to get this reversed, going from $250m a quarter to $34m a quarter seems pretty easy to convince the court.... Just a thought :)
True, but then again I didn't imagine Ampha getting approved or the CAFC lifting the PI either :P
Seems that way. It's really a shame what happened at the CAFC.
MNTAs EV is now around $180m
Even if the court allow the en banc, we still have another 4-6 month on top of that for their decision. I'm sure it will help the stock a bit short term, but I think the point is there really isn't any reason to own the stock right now...
not to my knowledge
Anyways, what's sad to say is that the long termers are now throwing in the towel, which is exactly the opposite of what they should have been doing.
Congrats Jbog. Hopefully you were shorting all the while.
On your market inefficiency comment, I would argue the market got "lucky" here. No one or their mother expected Amphastar to get approved (not a single analyst (not even the TEVA ones). Hell, not even WPI). On the court case, if there was a different panel, the PI never would have been lifted and MNTA would till be making $200m+ a year.
Regardless, you and IO were right. Bravo. Now what?