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Market: Wow.
yes. that was the fastest CC i've ever heard. no news, though they stated they are still optimistic on a decision in the near term. Now down nearly 2 bucks on no news and light volume. getting a bit silly. On the bright side -- the silly collapse allowed us to reach that 200dma. that should provide a floor for now.
MNTA: Is it just me or does 7% down on 90k shares (with no news) seem overdone?
MNTA: Down 86 cents on only 60,000 shares ... holy moly.... MNTA needs to get some IT staff to help them setup these conference calls ... first it was the grainy cowen conference call and now a botched quarterly conference call.
I encourage you to read:
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm119433.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm
Clue: Think about the term "generic" ... and the implications if the FDA asserts that sophisticated technology (that only one company possesses)is a baseline requirement to effectively characterize complex molecules (in such a way that they could be approved in an ANDA)
Your point is well taken.
The OGD is under immense pressure not to allow a single company to monopolize the commercialization of generic versions of complex molecule drugs.
It is predicated on (1) that discussion and (2) the uncomfortable political situation created for the director of the FDA-OGD by the MNTA mL ANDA.
MNTA: from the Q4 2009 conference call (Seekingalpha.com)
"Ziad Bakri – Cowen
Okay, I guess it has been three months now since you have been cautiously optimistic, how much time would have to pass from now before your level of confidence starts to decrease?
Craig Wheeler
That is a good question, but I do not have a good answer for you. I think my view on that is if I continue to see the signals that the FDA’s action gave to me in the application, I am going to feel pretty positive about it. If I feel things are stalled, my mood would change pretty quickly, but I do not feel that way right now."
MNTA: I suspect investors are fearful that Wheeler will announce his belief that the application is stalled within the agency. (something he alluded to as a possibility if approval is delayed indefinitely) Some analysts recently announced that they expected FDA approval of MNTA's mL in Q1-2010, but that the additional delay is NOT indicative of concerns around safety/efficacy of MNTA's mL, and that approval could be near.
I am a believer that we will see FDA approval-- MNTA mL substitutable and TEVA mL non-substitutable. FDA politics will likely force multiple approvals, but there should be sufficient flexibility for the agency to approve MNTA mL as a substitutable and TEVA's as a non-substitutable.
I bought my first batch of shares in 2005. I've not paid too much attention to the co. since that purchase.
But I've been accumulating aggressively over the past 3 months.
JP is the master of spin.
"During the teleconference the FDA noted that it felt that not all of their concerns were fully answered but opined that if the Company was willing to modify the trial from a parallel design to an escalating dose design the FDA would consider lifting the full clinical hold and place Proellex on partial clinical hold to allow the low dose trial to be conducted. The Company agreed to modify the protocol and submit the new design to the Agency as soon as possible."
How does such a statement warrant the stock moving as hard as it did? If anything, it cuts against the stock. What a joke.
Nice insight.
It is interesting to see so many analysts (e.g. Canacord, Rodman) put out notes that they expect approval "in the near term" notwithstanding that months have gone by since the company first asserted that they are optimistic about a FDA decision soon.
Craig Wheeler was asked a question about the limiting factors that could delay the FDA from making a decision -- his response leads me to believe that MNTA may be mulling taking legal action against the FDA (or at least they want the FDA to perceive that as a risk) -- Wheeler said they've satisfied all "technical, regulatory and legal issues" and that his optimism about a near-term approval would continue unless something occurred that led him to believe that the application was stalled. (my question: do months of waiting since satisfaction of "all technical regulatory and legal issues" constitute a stalled application?)
I believe the head of Sandoz went out on a limb in February and asserted that he also expects eventual approval of mL (but he was wise enough not to speculate on FDA decision timing).
Is there some other purpose behind Craig Wheeler's FDA mL timing commentary?
MNTA is presenting on Monday May 3rd at the Deutsche Bank Conference.
I wonder if they will give us a heads up on any talking points for the upcoming quarterly cc. Craig Wheeler put himself out on a limb when he asserted that they are "optimistic of a near-term approval" (back in November 2009). Did he really base this assertion solely on the fact that the FDA inspections of facilities went off without a hitch?
Let's hope for a approval in May or June!
MNTA: absolutely no volume. i could move the stock by selling just a small portion of my holdings... pretty scary.
MNTA: nice low-volume dip on no news ... good entry point for some calls and/or shares.
Dew, any thoughts on when the judge will issue the claims construction opinion for Sandoz/MNTA v. Teva? Oppenheimer expected a opinion in late March/early April...
"SUMMARY
On 1/20, we attended the Markman hearing for the case of Sandoz/MNTA vs. TEVA regarding generic Copaxone. While we are not patent attorneys, we believe Sandoz/MNTA made a strong case that the Copaxone patents are not specific enough to determine if M-356, or likely other generic Copaxone candidates, would infringe and that, critically, this is a fatal flaw of the patents. While we do not expect additional clarity until the judge's claims construction opinion is issued in 6-8 wks, we believe there is clearly the potential for multiple findings of indefiniteness which will likely strengthen Sandoz's case for invalidation of the patents, longer term. We would add to MNTA positions coming out of the hearing. Increasing PT to $17 (from $15). "
I posted the MNTA 5 year resistance (chart) on the SI forums ...
http://twitpic.com/1hog79
major resistance @ 15$. But if MNTA can break through that resistance, a big technical run could ensue. Who knows... we might get the run without mL approval (if some other major driver emerges)
Pretty amazing ... NVS has outperformed MNTA this year.
http://finance.yahoo.com/q/bc?t=1y&s=NVS&l=on&z=m&q=l&c=mnta
Very frustrating.... no decision, no communication ... i wonder what Craig Wheeler will say at the May CC.
MNTA:
Interesting to watch the action. Looks like quite a bit of resistance north of 15$, when it couldn't break out past the resistance it fell back to the $14 support. The pendant broke to the downside, so it looks like a short-term negative trading situation. That being said, the stock is driven largely by binary events ... with the FDA decision expected any day now, I don't think sellers will come out in droves. I am loading up, to the extent I can afford to do so ... ;)
FYI: MNTA - 1st quarter earnings call is scheduled for May 6, 2010. Confirmed by MNTA IR.
Dew, how do you square this acquisition with post #48028530 .... http://investorshub.advfn.com/boards/replies.aspx?msg=48028530
I'm surprised MNTA didn't move higher on this news.
January 20th + 90-180 = April - July (I expect that we'll hear something in April or May). mL "decision purgatory" is painful.
Do you see the price running up to $25-$30? Did you see my post earlier on FDA politics? The FDA head of biogenerics would need to undermine his own political position by approving MNTA's mL as the sole generic. (i.e. if he admits that MNTA's sophisticated technology is required to adequately characterize this LMWH, then he would be acquiescing to others in the FDA)
Who would win in a sole generic approval ... only MNTA .... who would win in a multi-generic scenario: the FDA, MNTA, TEVA and the biogeneric community as a whole. Multi generic approval would also reinforce what the FDA has been looking for since the Amphastar allegation ... lack of impropriety between MNTA and the FDA during the Heparin scare. I am a MNTA long, but the more i think about this, the more i see a multi-generic approval scenario. I still think the price would run-up to $30-$40.
There was a big run-up last quarter. Most analysts have their price targets between 15-17 ... Until we get some new news, I see the trading range between 12 - 18
MNTA - head of FDA biogeneric division may feel compelled to approve TEVA and MNTA's mL (multi-generic scenario) ... purely due to FDA politics. I still think MNTA would be worth 30$-40$ in such a scenario.
How amazing....
Indeed... but I'm hopeful that they care as much about the science as they do about the money.
MNTA - dead silence for weeks now.... Company has been quiet for nearly a month (since the Cowen conference). Per IR, no events scheduled other than the May CC. I wonder what they are up to over there as they burn through all that cash. Hope those nerds have something to show for it at some point in time.
Isn't biotech investment largely speculation? :)
Thanks for your feedback, I value your opinion.
There are several posts on the board about SQNM. Many are skeptical about the prospects of the co. (justifiably so after last years mishandling snafu) I am cautiously optimistic that the DS test will eventually be commercialized based on inferences from on-going activities.
Thanks for the feedback.
I agree that the activities surrounding the DS test have been, as you put it so eloquently, "noisy." That being said, I think making an assumption of out-right fraud is premature. It could as easily be sloppy P&P's in R&D.. Keep in mind that the co. has already preliminarily settled it's shareholder lawsuit (scheduled to finalized on May 3rd). Attorneys for plaintiffs have already agreed to 14 million $ (all from insurance -- which interestingly enough does not cover fraud, but will cover this "mishandling") and issuance of 10% of shares to plaintiffs. It is interesting to see plaintiffs (which appear to include RA Capital and Ridgeback) accept stock in lieu of cash.
The Sensigene lawsuit has also been settled (after SQNM agreed to issue them shares). It appears that the majority of those hurt (shareholders, third-parties, etc.) by the "mishandling" are accepting shares are recompense for their damages -- would they go this route if they felt that co. had no viable DS test?
In my opinion the company already disclosed what happened ... the remediation steps in the shareholder settlement stipulate everything from revised R&D controls, to enhanced HR training for employee email use, independent directors, etc... in contrast to your "fraud" conclusion, I infer sloppy R&D and poor management, not outright fraud.
That being said, I am impressed by your due-diligence... particularly your reference to the revenue numbers for the CF test in the 4th Quarter. But in all fairness, there is some additional color (provided at the Q4 CC) that puts that very low number in context:
http://seekingalpha.com/article/193823-sequenom-inc-q4-2009-earnings-call-transcript?page=-1
"Diagnostic revenue for the quarter was derived only from our carrier screening tests for cystic fibrosis, which we commercialized in September of 2009.
Diagnostic revenue is currently recognized upon cash collection, as payments are received. Diagnostic revenue going forward will be unpredictable due to the lack of historic sales trends associated with our recent commercial launches. We anticipate that by the end of 2010, we will have accumulated sufficient historic diagnostic revenue information and secured enough health plan contracts to move from a cash basis of revenue recognition to an accrual basis. And from a reimbursement perspective, it is worth noting the following.
Our fetal sex determination test is a patient paid test. We will not bill or receive insurance reimbursement for this test. Our cystic fibrosis carrier screening and fetal RhD tests are reimbursable from health plans. We have an experienced head of managed care [recent hire] who is spearheading our discussions with payors. We are in the process of engaging with payors across the U.S and in the meantime in geographies where we do in the have an agreement in place our tests are reimbursable through the patient's out of network benefits."
RKRW, we shouldn't be overzealous in our analysis. The "mishandling of data" does not necessarily constitute falsification. There is an allegation in the Xenomics lawsuit that SQNM falsified data (to induce Xenomics into a licensing agreement), but at this stage it is nothing more than an allegation. (BTW the case is now going into arbitration). I don't believe that SQNM's IP (DNA or RNA) related to the DS test is under serious threat of compromise. The next big catalyst is Dr. Lo's disclosure of study results (see below). I suspect Lo/SQNM are being extra careful this time around to ensure no data is prematurely leaked without careful analysis.... The co. successfully launched their Fetal XY, RhD and Cystic Fibrosis test recently and I suspect they will eventually commercialize the DS test. Cheers....
TUESDAY, MARCH 30, 2010 ET
Sequenom: Still Awaiting December Test Data
By TIERNAN RAY
Shares of biotech Sequenom (SQNM) are up 51 cents, or 8%, at $6.66 (an eerie number) on what appears to be “chatter” regarding the company’s non-invasive genetic tests in development, according to Briefing.com.
Raj Mehra with Auriga Securities cast doubt on the likelihood of any news today regarding the company’s non-invasive prenatal Down Syndrome genetic test, a market that’s worth potentially billions for the company.
The market, Mehra notes, is awaiting the results of a 700-sample study conducted in December by Dr. Dennis Lo, a pioneer of the approach upon which Sequenom’s Down test is based, with whom the company maintains a close relationship.
But Dr. Lo has declined so far to provide that test data, as he’s still going over the results, according to Mehra.
“Once that study is hits, in June, July or August, we’ll know if the [Down Syndrome]test can be commercially viable,” Mehra said in a telephone call today.
Until then, it appears chatter is just that.
MNTA - Alan Crane resigned from BOD on 3/31. No reason given.
what about SQNM?
Finally! Just what we've all been looking for... more roller-coaster MNTA heart-ache. Very cruel ....
Pop is the result of "market chatter" (anticipation that Dennis Lo will soon present favorable DS test sample data)
http://blogs.barrons.com/stockstowatchtoday/2010/03/30/sequenom-still-awaiting-december-test-data/tab/print/
Sequenom: Still Awaiting December Test Data
By TIERNAN RAY
Shares of biotech Sequenom (SQNM) are up 51 cents, or 8%, at $6.66 (an eerie number) on what appears to be “chatter” regarding the company’s non-invasive genetic tests in development, according to Briefing.com.
Raj Mehra with Auriga Securities cast doubt on the likelihood of any news today regarding the company’s non-invasive prenatal Down Syndrome genetic test, a market that’s worth potentially billions for the company.
The market, Mehra notes, is awaiting the results of a 700-sample study conducted in December by Dr. Dennis Lo, a pioneer of the approach upon which Sequenom’s Down test is based, with whom the company maintains a close relationship.
But Dr. Lo has declined so far to provide that test data, as he’s still going over the results, according to Mehra.
“Once that study is hits, in June, July or August, we’ll know if the [Down Syndrome]test can be commercially viable,” Mehra said in a telephone call today.
Until then, it appears chatter is just that.
MNTA is already aware of the biotech tax credit(s). The current employee headcount is ~170. See IR email below.
"Thank you for your recent email. I have passed the email along to our finance department who appear to be aware of the situation.
In answer to your question regarding headcount, we have approximately 170 employees.
Best,
Beverly
Beverly Holley
Director, Investor Relations
Momenta Pharmaceuticals, Inc.
675 West Kendall Street
Cambridge, MA 02142
(617) 395-5189
bholley@momentapharma.com
www.momentapharma.com"
It may help to keep the move from 14 -> 15.50 in context. The drop to 14 took place rapidly ahead of options expiration. We are now back even. The drop did not adversely affect the call premiums.
MNTA - received response from IR about Barclay's conference:
"Thank you for your email concerning the Barclay’s conference. From time- to-time we encounter scheduling conflicts that require us to withdraw from conference presentations. Our next scheduled event is our 1st quarter earnings call which is scheduled for May 6, 2010.
Cordially,
Beverly Holley"