Momentas Opportunity-mnta*

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stonedinvestor

Folks I'm backing up the old station wagon and loading up the MNTA today. There is PR release today getting NO LOVE THAT IS HUGE FOR THIS CO..... Read it, I'll post it in a bit... Not only that they were upgraded by Rodmin & Renshaw yesterday; not only that NotableCalls had a piece out this week on the name that I put in my Where We're At thread-
On NotableCalls this caught me eye
Morgan Stanley is upgrading Momenta Pharma (NASDAQ:MNTA) to Overweight-V and increasing their target to $22. Firm believes the stars could be finally aligning for the FDA approval of MNTA/NVS’s M-Enox in 2008-09 as the only genericversion of SNY’s Lovenox (blood thinner), potentially leading to: 1) 40-50% share of the $1.5+ billion U.S. Lovenox market, 2) peak potential earnings of $3/sh and 3) a share price of $40+. The downside risk of a long delay or non-approval is that the stock returns to $6.

Why are they upgrading now? Firm believes that the heparin (a complex sugar) contamination crisis may have given MNTA the unique opportunity to prove to the FDA its proprietary technology for characterizing complex sugars. Last week’s Nature publication shows that MNTA worked with the FDA to identify the heparin contaminant. They view this work as a game changer, underestimated by the Street. In our opinion, the FDA is now more likely to view MNTA’s technology as sufficient to show that M-Enox is the same as Lovenox (also a complex sugar) — a key regulatory hurdle and one they feel competitors Teva and Amphastar cannot achieve.

Notablecalls: This is a game-changing upgrade for this stock. Morgan Stanley has been neg on MNTA for quite some time (UW rating) and now they are saying the stock could do $35+ under bullish scenario.

The NC crew missed the fact that a news release further down shows MNTA announcing a presentation at.... of course Morgan. It's always hard to figure out the order of these things is the presentation set and then as luck would have it herceptin gets tainted or does the Co have a story to tell now... the fact that the co worked with the FDA in the emergency lends major creed to their case in my view. Perhaps sometime between today and the presentation Wed this could be bought for a nice hold. Big price target.

Ok we have new FDA news going into a speech today and a stk not reacting @$15.... opportunities like this is why I keep my nose to the grindstone every day. I bought this name lightly yesterday in anticipation of the analyst meeting at Morgan as well now we have an upgrade this news and another presentation on May FIVE..... This has some BIG possibilities a large super drug to be sure and a co that now seems to be on the same page with the FDA... this is a 1 year DOUBLE. Stoney PT. ~ $30.
 
Press Release Source: Momenta Pharmaceuticals

Momenta Pharmaceuticals Receives Regulatory Guidance On M-Enoxaparin ANDA
Tuesday April 29, 5:50 pm ET
Company Expects to Submit Amendment to ANDA in Third Quarter, 2008

CAMBRIDGE, Mass., April 29, 2008 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM:MNTA - News), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Food and Drug Administration (FDA) has provided guidance regarding the Abbreviated New Drug Application (ANDA) for M-Enoxaparin. Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox(r), in collaboration with Sandoz, the generics division of Novartis AG.

Earlier this year, Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time.

``We are pleased that the FDA has clarified our path forward for M-Enoxaparin by providing written direction regarding their expectations for our application,'' commented Craig A. Wheeler, Chief Executive Officer of Momenta. ``We are still evaluating the FDA's guidance, but, based on our preliminary assessment, we hope to submit the amendment conta
 
It's like I imagine being a baseball player on a hitting streak when even the bloops are falling in... Someone misread the press release? Actually there is an open ended phrase in there that I of course read as madly positive that the FDA did not request human testing at this time... that seemed like expediated timeframe to me... of course biotech is a minefield and you never know when they turn that same sentence against you... we need to go to trials now! Anyhoo darn if this stock didn't dart down this morning so when we all bought look at the price we got!!!
LOL now look now! YOU COULD OF HAD THIS AT $14.25 FOLKS!!!!!! Ayyyyyy Caramba NOW IT'S UP 3% The old 6% gain off the bat!!!!It's silly time folks and I'm your merry merry leader... boy I'm zonked already and it's 10:10. If I was drunk you would call me an alchohloic this is slightly desturbing, I need to look in the mirror... but it's part of my trading style and brilliance ugh my heart! And now a Kung Fu workout ontop of eight or ten cups of coffee and all this morning angst waiting and victory laps... oh what a life of high blood pressure. Ct tomorrow. My steam. My stream oh how I miss thee quiet of my stream...~ stoney
 
Therm you ungrateful reactor, if you didn't make money off this today your hands were down your pants... man a clean $1 and you didn't scalp any?
You should be ashamed of yourself we made money on the name twice today... & I have it $14.37 for a long term position all my guys made hay with this name today. Hurrumph! ~ stoney
 
Motley Fool Chirps in I usually hate these guys unless it's a stock I like in which case I agree like crazy.

Momenta Restarted

By Brian Orelli April 30, 2008
1
Recommendation

It was the best investors in Momenta Pharmaceuticals (Nasdaq: MNTA) could have hoped for. Eleven short words may mean the difference between an approved drug and one that was scrapped.

"The agency has not requested human clinical trials at this time."

That sentence was in a press release about Momenta's generic version of Sanofi-Aventis' (NYSE: SNY) Lovenox for blood clots, which the company is developing with partner Novartis (NYSE: NVS). The Food and Drug Administration rejected their abbreviated new drug application (ANDA) last November because the agency was worried about the drug's potential to cause an immune reaction. Momenta will have to do some additional tests on animals and submit additional information, but no clinical trials are required.

If the FDA had requested clinical trials to prove that the drug worked, the duo might have just scrapped the project. The generic drug isn't expected to fetch as high a price as its branded counterpart, so the return on investment in a clinical trial might have been extremely low.

Lovenox is a pretty complex molecule. It's not as complex as protein-based biologics, but certainly more complex than your average small-molecule drug that's typically approved through the ANDA process. The fact that the FDA is requiring Genzyme (Nasdaq: GENZ) to run clinical trials for its own drug just because it's being made at a different facility now seemed like an ominous sign for Momenta, but I guess the company has convinced the FDA that its knockoff is the same as Sanofi's Lovenox.

No word yet from Teva Pharmaceutical (Nasdaq: TEVA) and Amphastar, which are developing their own generic version of Lovenox, on whether they've also cleared up what they need to do to gain approval.

Momenta expects to submit the additional information to the FDA in the third quarter of this year. Generic-drug makers don't have a Prescription Drug User Fee Act (PDUFA) set up, so there's no way to know how long it could be until the drugmaker hears back from the agency. Last time, it took more than two years to hear that the FDA wanted additional information. It's hoped that Momenta, a Motley Fool Rule Breakers pick, hears back much more quickly this time.
 
Quote from stonedinvestor:

Therm you ungrateful reactor, if you didn't make money off this today your hands were down your pants... man a clean $1 and you didn't scalp any?
You should be ashamed of yourself we made money on the name twice today... & I have it $14.37 for a long term position all my guys made hay with this name today. Hurrumph! ~ stoney
More...
hahaha!! dude your posts are always fun to read and you've had some great picks over the times. Lousy FED action might be to blame for the downswing today, though the stock IS trading at/near highs - it was $3 a few months ago after all.
 
Your kidding me Therm it was $3? I've got to broaden out from the 3 month time frames. I was a little grumpy when I returned that post to be honest I didn't unload enough on the big spike. What I failed to do is go over to a message board and see that the big analyst meeting had become so well known that people were hoping for some piece of news not already given.... the great irony of course being that if the co had left it at that no human trials draw your own conclusions... we'd be up a buck. Sometimes too much publicity is just that. Now I've bothered the big wigs and stuffed another high beta name into what's supposed to be a more stable account along with CEGE, CPST, AIXG, CLWR and this! I'm unraveling in a way & everything's way up which is the funny thing but my adding this name.... my guys are looking at me I can tell...... it might be time for stoney to place some heavy objects on himself and lie on a nailbed. If Momenta would agree to explode $10 next week thru the other analyst meeting on the 5th.... I will sell and stop trading for a while... I promise... just let that happen...please! ~stoney
 
Ok Stoned, I'm at 14.02

I think you're right on this one. Let's see what happens on the 7th. I've got a lOOSE stop at $8. But, MNTA was at 29.09 a few years ago.:cool:

Love to ride that one up. The chart looks like it's off to the races on MNTA.:)

Now that I've got my order in, will you please give Warren Buffet a call, and have him buy drop a few hundred million $ into MNTA?:D

Btw, here's the link to the call:
http://www.primenewswire.com/newsroom/news.html?ref=rss&d=141651
 
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