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This is the 5th job opening in 2 weeks.
For several months prior, there were NO job postings. The $$$ must be FLO-ing.
Scientist, Bioanalytics
I would like make some other presumptions on MNTA hiring five scientists in such a very short period.
We have just gone through a very unusual period and difficult time in this area of employment.During the last two years many very qualified successful scientists have lost jobs mainly due to mergers and big pharma downsizing.Now many of these talented people quickly found jobs.
My point here is that this may be the best time in our lifetime for a small company looking to locate some gifted people.
Some companies are thinking of doing away with research altogether.
I do not know of any association of hiring high level scientists and a stock price but probably would make an interesting paper for some poor grad student.
These are not menial hires and are not being added without a great deal of vision. I presume now that the biggest hurdle ( recognition of their platform ) has been accepted that they are very confident and are moving ahead at breakneck speed in several new areas of development. Of course lots of things that never happen are fabricated in my mind.
Ph.D. in Bioanalytical Chemistry, Analytical Biochemistry or related discipline, with a minimum of 5 years relevant hands-on experience beyond degree. Will consider a B.S. or M.S. in the fields listed above with a minimum of 8 years of relevant hands-on experience.
Prior experience with a variety of complex analytical, physical, and bioanalytical (bioassay, immunoassay, cell-based assay) measurement techniques.
Experience with assay qualification, validation, and transfer in a cGMP environment
Demonstrated strong experimental design and problem solving skills.
Strong statistical and data analysis skills required.
Firm understanding of GMPs, GLPs, 21 CFR Part 11 and FDA/EMEA Bioanalytical Guidance required.
Demonstrated collaborative capacity.
Are you speaking of the hypothetical unrealized value today ?
Also is that a per year number ?
I would think as each of these potential events are realized the value would be much greater but i am not even doing napkin calculations so my ideas are not as concrete as yours.
Are we sure there is little news in the coming months ?
with little news from MNTA in coming months
Cardiff trial for new hepatitis C drug 'successful'
Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.
The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.
Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.
Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".
Continue reading the main story
Related stories
New hepatitis C drug trials begin
Lab advance aids hepatitis fight
Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.
The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.
Side effects are often severe and lead to patients failing to complete the treatment.
But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
Continue reading the main story
“
Start Quote
The drug is safe, with no drug-related side effects at all in a single dose of 100mg”
End Quote
Prof Chris McGuigan
Welsh School of Pharmacy
"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.
The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.
It has been cleared for human clinical trials by the Food and Drug Administration in the US.
http://www.bbc.co.uk/news/uk-wales-south-east-wales-11165262
I give up i am not going to continue to debate such a small point but my reasoning does have merit.
Price =Promotion
Maybe i am wrong but i have dealt with the FDA and i know price is considered promotional in nature.
Of course i have no experience in the generic arena and it may be different or maybe i am just so shell shocked from my every encounter with an FDA regulation i always go for the more conservative interpretation of the rule
What do you mean what am i driving at ? I was responding to a post commenting that TEVA was discussing price on a drug they have not even received approval on.You commented with your opinion and i asked you for your source.When challenged you ask me what is the point of this ? What is the point of any discussion here ?
It may be obvious to you but that does not make it obvious to the FDA.I think you are wrong
Discussing a proposed price for a hypothetical product with a prospective distributor does not constitute illegal drug promotion.
I do not believe that that is accurate .Please show your source.
Hypothetical and FDA are not two words that mix easily
I can not find the exact FDA regulation to see if they explicitly spell out price.But remember price discussions are a form of promotion.I did find a device statute which comes close to what i was thinking .Remember selling on price is a promotional strategy in nature.Its so damn hard to find anything in searching the FDA
Prelaunch promotions. Devices that are pending clearance or approval cannot be promoted. This applies to all product literature, labeling, communications, and advertising. Likewise, the indications for use may not be stated or implied, and no claims of safety or efficacy may be made. This is because prior to clearance or approval, the manufacturer cannot ascertain which claims will be accepted by FDA. Therefore, the device cannot be considered safe or effective. The investigational device exemption (IDE) regulations also prohibit promotion of devices that have not yet been cleared or approved for marketing by FDA. This includes promotion or test marketing of investigational devices, or representations made that a device is safe or effective for the purposes for which it is being investigated. It should be noted that companies can communicate prelaunch information about unapproved products by using press releases on product development activities and having scientists provide presentations at meetings, within the context of a scientific and educational activity.
" An interesting aside to this is that Healthtrust (HPG) informed its members that it is negotiating with Teva for the price of their (yet-to-be-approved) enoxaparin. "
I do not believe that promtional nature of any unapproved drug including price is legal . Am i wrong on this ?
For me after watching the last hour and the volume increase i would guess that there is still some shorting going on.Between 26 and 14 we have already seen more volume selling than was bought over those up days.Of course i haven't taken the time to do the calculations to add up the shares bought up to 26 vs shares sold down to 14 .This is just my conjecture.Its always like walking down a blind alley for me when i try to understand the wacky market
Those are sure small interesting amounts of shares sold.
Is there a reason for such small odd lots ?
Also do you think they just do not sell all at once is to protect the price ?
Or are they restricted ?
Yep another logical reason for an illogical stock price.
It is like surgery with little or no anesthesia.
Things look like they are going well but it sure hurts
MNTA
Maybe insiders are still selling or it is being shorted.Any rational long term investor selling does not seem to make sense.
Wierd i thought with the approval that 18 was a floor.I hope it doesnt turn out to be a trap door.It sure is painful to watch
Repost from another board. MNTA
My comments are that " I really do not buy technical analysis but always find it interesting to look at." I wonder if somehow TEVA is getting approval this week and somehow word has leaked as usual.I can not think any other reason MNTA is back to a pre approval price . "
http://www.smallcapnetwork.com/There-Are-Several-Ways-to-Skin-a-Cat-Looks-at-PAY-MNTA-and-EMIS/s/article/view/p/mid/3/id/413/
Remember Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA)? I actually posted a near-term bullish outlook for this small cap biotech stock back on July 27th when MNTA was trading at $23.23, but struggling with the weight of a massive runup just a few days before.
Well, I caught some flack about the call (the die-hard believers in Momenta Pharmaceuticals), and was called some pretty choice words. Needless to say, the pullback to a low of $14.67 was more than vindicating.
I don't come here to gloat though, as I can be wrong just like anybody else. I came here to let you know I think it's safe to get back in the water here. Momenta Pharmaceuticals, Inc. has more than amply bled off the overbought pressures, and appears to be in rebound mode. I just wish today's gap was closed.... and maybe it will be soon enough.
This is a slide from a recent CME program that i completed.
I find the ITPA genotype information very interesting .
New Factors Influencing Response
• Insulin resistance and hepatic steatosis decrease
response to treatment
– However, preliminary results using pioglitazone have
not demonstrated an enhanced antiviral response at
12 weeks1
• IL28B is perhaps the most useful new tool
• ITPA genotype may identify patients who are able to
tolerate high-dose RBV without significant anemia2• Vitamin D deficiency may impair response, and
supplementation may enhance it3
1. Harrison SA, et al. [Abstract 535]. Presented at: 2010 Digestive Disease Week; May 2-5, 2010; New Orleans, LA.
2. Thompson AJ, et al. [Abstract 2015]. Presented at: International Liver Congress 2010--45th Annual EASL Meeting;
April 14-18, 2010; Vienna, Austria.
3. Abu Mouch S, et al. [Abstract 55]. Presented at: International Liver Congress 2010--45th Annual EASL Meeting; April
14-18, 2010; Vienna, Austria.
I also asked about Presidio and he thinks they are a small player right now but he also thinks if they do advance that BMS would litigate immediately since their guy came from BMS and they develop a similar program very quickly.
Well i had breakfast with one of the leading Hepatoligist investigators in the field this morning and he told me that the NS4B data he has seen looks very good.He is not going to name the company because he is sworn to confidentiality .It doesn't mean thats it is Eiger either. I guess its possible that some companies are developing molecules that have not been publicized yet.As a side note he thinks Pharmasset is doing good things.He likes their research people.He said he is giving everyone Vitamin D not just deficient Vitamin D Hep C patients.He says it acts as a booster even if a patients Vitamin D is at a normal level.No scientific confirmation yet but he and several of his colleagues swear it is upping the SVR in current SOC compliant patients.
NS4B
Can anyone tell me .
Who is in the lead developing this inhibitor ???
I have no opinion on Immunogen but this author ( love his photo ) seems to like it.
I know that some Bio techs offer a good opportunity after they plunge.That is why i like MNTA so much here.Each case though is very different.
Why I Bought ImmunoGen After the Plunge
ImmunoGen (IMGN) is a Waltham, Massachusetts based biotechnology company. On Friday August 27th, 2010, their collaborative partner Genetech, a member of the Roche Group, received a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Bilogic License Application (BLA) for trastuzumab-DM1.
IMGN stock plunged from $8.40 the day before to $5.90 premarket. At the end of the day the stock rested at $5.16; see the chart following for the plunge.
Click on link for charts and rest of article
http://seekingalpha.com/article/222755-why-i-bought-immunogen-after-the-plunge
Cocktails Are Next For Cancer-Drug Makers
Big Pharma turns to the multi-drug approach that transformed AIDS By Tom Randall
That's the bet being made at Roche Holding, AstraZeneca (AZN), and Sanofi-Aventis (SNY), whose latest efforts to develop a new generation of combination treatments are prompting the U.S. Food & Drug Administration to rewrite the rules for drug research. The FDA guidelines, not yet public but expected this year, may shave five years off development time lines and lead to dramatically better drugs, says Ira Mellman, head of cancer research at Roche's Genentech unit.
For more than a decade, cancer researchers have been crafting drugs to disrupt the precise cellular processes that fuel cancer, creating a $51 billion market in 2009. So far, the survival benefits have been measured in months, not years. That's because cancer, like the virus that causes AIDS, evolves rapidly to evade a single treatment. Rather than mixing and matching approved drugs, researchers are developing new, targeted combinations that work in tandem to block cancer.
"We're looking to see a radical change in terms of stopping the disease in its tracks," says Tal Zaks, head of global oncology drug development at Sanofi in Paris. "The return on investment here is not going to be just evolutionary; it has the potential to be revolutionary."
Cocktails of experimental drugs wouldn't have been possible just five years ago, when FDA rules required that the merit of each active ingredient be proved before it could be added to a combination. The FDA worried about approving a combination in which one part was useless, or worse, harmful.
Today, after 20 years of work on the human genome, scientists have new insights into the cellular and genetic links between different disease pathways. As a result, the FDA is ready to allow testing of drug cocktails designed to hit cancers at multiple points, says Richard Pazdur, the FDA's top cancer regulator. "This is an era of a greater understanding of the disease," Pazdur says.
Savings for drugmakers could be substantial if the FDA, as expected, sets up a path to allow companies to forgo differentiating the drugs during the last and most expensive trials needed for regulatory approval. Those studies, pivotal phase III trials, can cost hundreds of millions of dollars and take years to complete.
Companies are taking different approaches to combination treatments. Pfizer (PFE), the world's biggest drugmaker, and Roche, the world's largest maker of cancer medicines, are developing the needed parts in their labs. Roche's leading combination began safety tests in patients this year, and Pfizer has four combinations in early human trials.
A second group of companies is looking outside to acquire components. Novartis (NVS) and GlaxoSmithKline (GSK) started two studies this year combining an experimental drug from each company. AstraZeneca and Merck also began a collaborative trial. Meanwhile, Sanofi has licensed a molecule that inhibits a cancer-related enzyme from Exelixis (EXEL) and an antibody against a separate protein target from Merrimack Pharmaceuticals. It will combine the two into a new drug based on a recipe concocted by its own scientists. Such collaborations and acquisitions are likely to increase as FDA regulations are clarified, Zaks says.
Combining drugs is not new. Doctors began mixing chemotherapies more than 40 years ago to reduce side effects and improve outcomes.
Compared with targeted therapies, though, chemo can be a blunt instrument that wipes out a wide swath of cells, including healthy ones.
Cancer begins when a gene mutation triggers some cells to divide faster than normal. Aberrant cells multiply to form tumors with billions of units competing for blood nutrients. The competition and rapid reproduction yield additional mutations that help the cancer grow and eventually take root in new organs. Through similar adaptations, cancer develops resistance to medicines.
The first studies of targeted cocktails better able to prevent cancer from escaping will be released in 2012, says Harish Dave, global head of hematology and oncology at clinical trial firm Quintiles Transnational, which had a role in 48 of the 50 best-selling cancer drugs. "We may see something very interesting come out," he says. However, the risk of the therapy "is that you could be shutting down so many activities in the cell that it could be toxic."
Cancer drugs aren't cheap. Dendreon's (DNDN) Provenge treatment for prostate cancer, for instance, sells for $93,000 for the one-month, three-dose cycle. Total sales of cancer drugs have risen 10 percent to 20 percent a year for a decade, according to research firm IMS Health. And combinations of cutting-edge targeted drugs will likely drive costs for patients and insurers even higher, since each component is so expensive.
"Five years ago, you couldn't get companies to agree to combine their agents," says John J. Wright, a senior investigator at the National Cancer Institute's drug evaluation program. That led the NCI to broker a legal framework—assuring each company maintains rights to its components during cocktail trials—that's leading companies to collaborate.
The first combinations available to patients will be mash-ups of existing treatments, such as Roche's Avastin and Bayer's Nexavar. Yet Roche's Mellman says combinations of pre-approved treatments are "old school," and that the real potential for drugmakers will be in the next generation of targeted cocktails, "driven by scientific discovery that starts in the laboratory."
The bottom line: Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer.
Randall is a reporter for Bloomberg News in New York.
http://www.businessweek.com/magazine/content/10_36/b4193020841268.htm
In the pharmaceutical industry, companies like Merck /quotes/comstock/13*!mrk/quotes/nls/mrk (MRK 34.48, -0.06, -0.17%) , Pfizer /quotes/comstock/13*!pfe/quotes/nls/pfe (PFE 15.90, -0.09, -0.56%) and Sanofi-Aventis /quotes/comstock/24s!e:san (FR:SAN 44.57, -0.12, -0.26%) have large sales forces and lots of drugs coming off patents. That means they need new drugs to sell. Meanwhile, the companies have a lot of cash, so they can buy biotech companies that have been developing new drugs, Gerbel explained.
Sanofi is in talks to acquire biotech firm Genzyme Corp. /quotes/comstock/15*!genz/quotes/nls/genz (GENZ 66.84, -0.74, -1.09%) , the Wall Street Journal reported in early August. See story on deal talks.
The two companies are struggling to agree on a price, according to more-recent media reports. But, given how buoyant the M&A market is, this may be a deal that's announced later in the year.
"August is traditionally the slowest month for M&A, but this year it's been huge," Gerbel said. "When people return from summer, there'll be a tremendous amount of activity late this year and early next year."
http://www.marketwatch.com/story/a-busy-august-fuels-ma-speculation-2010-08-27?pagenumber=2
I am gratified for the recent promising treatments for melanoma.
I can only dream that recent developements will pan out for people who suffer from Metastatic melanoma .
I also think the shorts are not covering but adding to their positions but this is only a guess
I maintain my morning sneaking suspicion !
Hope you are right.My thought on the shorts not covering is a total guess
GLTA
Great premarket volume.Lots of new buyers Crossing the CNBC ticker heavily in premarket trading which is good and bad because we may get the Mo Mo crowd . I also think the shorts are not covering but adding to their positions but this is only a guess.MNTA has the highest short interest in at least a year if not ever.
Well the overall daily volume was low and then there was a short period when someone wanted a fair amount of shares all of a sudden.We know how tight lipped these rulings are but someone always finds out and makes a purchase.Sometimes is much more obvious .If i had to make a wild guess i would say this was not an institution but probably some friend of a court clerk putting his entire portfolio into MNTA at around that time yesterday.
" useless "
In response, the federal defendants argue that the Court
must reject Sanofi’s assertion of irreparable harm, explaining
that “n this circuit, mere economic loss – even irrecoverable
10
the Court finds no reason to doubt the FDA’s explanation
regarding its request for additional information relating to
impurities.
14
Therefore, given the deferential
standard of review that this Court must accord the FDA’s
scientific determinations, the Court finds it unlikely that
Sanofi will succeed in its argument that the FDA’s approval of
generic enoxaparin is inconsistent with its past precedent.
3. FDA’s Determination that Sandoz’s ANDA has the
Same Active Ingredient as Lovenox
Finally, Sanofi argues that it is likely to succeed on the
merits because the FDA approved generic enoxaparin without
Opp’n Br. at 32 (“Omnitrope, unlike enoxaparin, was never
determined to have the ‘same’ active ingredient as the innovator
[RLD], and in fact had acknowledged differences in certain
respects. Thus, it was not approvable as an ANDA under 21 U.S.C.
§ 355(j)(2)(A). By contrast, FDA has determined that Sandoz’s
enoxaparin has the ‘same’ active ingredient as the listed drug,
Lovenox, because it has been adequately characterized and has met
the five criteria.”); Fed. Defs.’ Opp’n Br. at 33-34 (“In its
Premarin decision, FDA determined that it would not accept an
ANDA for a synthetic (laboratory-synthesized) version of Premarin
because the RLD was not adequately characterized. FDA stated,
however, that it could approve generic copies of Premarin if they
originated from the same natural source material (pregnant mares’
urine) and were subject to similar manufacturing controls. FDA’s
enoxaparin decision is consistent with its decision for natural
sourced Premarin because generic enoxaparin is derived from the
equivalent source material and is manufactured using a wellcontrolled
process.” (internal citations omitted)).
24
sufficient evidence that Sandoz’s ANDA has the “same” active
ingredient as Lovenox as required by § 355(j)(2)(A). Sanofi
contends that in approving Sandoz’s ANDA, the FDA “ignored
voluminous scientific evidence demonstrating that until
enoxaparin is fully characterized, generic enoxaparin products
that do not use a manufacturing process that is equivalent to
[Sanofi’s] process will not be the same as Lovenox.” Pl.’s Mem.
at 33. It further asserts that the FDA failed to provide a
“rational explanation for its decision to disregard scientific
evidence that directly contradicts its administrative findings,”
and therefore is arbitrary and capricious. Pl.’s Mem. at 33-34.
The Court finds these arguments unavailing.
In its response to Sanofi’s citizen petition, the FDA
provided a detailed explanation regarding its determination that
an ANDA applicant for enoxaparin can demonstrate “active
ingredient sameness” by meeting five criteria, “each of which
captures different aspects of the active ingredient’s
‘sameness.’” AR 2879-80. In particular, the FDA found that an
ANDA applicant seeking approval for generic enoxaparin must
demonstrate: (1) equivalence of physicochemical properties, such
as molecular weight distribution and overall chemical
composition; (2) equivalence of heparin source material (i.e.,
heparin that is derived from porcine intestinal mucosa and that
meets USP monograph standards for Heparin Sodium USP) and mode of
25
depolymerization (i.e., cleavage by alkaline ß-elimination of the
benzyl ester derivative of heparin); (3) equivalence in
disaccharide building blocks, fragment mapping, and sequence of
oligosaccharide species; (4) equivalence of in vitro biological
and biochemical assay results; and (5) equivalence of in vivo
pharmacodynamic profile based upon measurements of in vivo anti-
Xa and anti-IIa profiles. See AR 2888-900. The FDA also
provided an exhaustive response to the arguments raised in
Sanofi’s citizen petition, see generally AR 2904-21, including
Sanofi’s claim that the FDA should refrain from approving any
ANDAs citing Lovenox as the RLD unless, among other things, the
manufacturing process used to create the generic drug product was
deemed to be equivalent to Sanofi’s manufacturing process for
Lovenox. See AR 2905-13 (explaining why ANDA applicants for
enoxaparin do not need to demonstrate that they use the same
manufacturing process as Sanofi).
I asked a question around 3:30 pm about an unusual spike in volume during a very short window.I know the last trade was 17$ in the after hours , maybe it holds and maybe it doesn't but i know what i saw on level 2 was increased interest that is why i asked about any news.
MNTAMomenta Pharmaceuticals, Inc. (MNTA) After Hours Trading Pre-Market Charts | After Hours Charts Aug. 25, 2010 Market Close: $ 15.68
After Hours Last:
Net / % Change $ 17
1.32 (8.42%) After Hours High: $ 17
After Hours Volume: 46,094 After Hours Low: $ 15.3061
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=MNTA&mkttype=after
Read more: http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=MNTA&mkttype=after#ixzz0xfJSW300
Also the last 30 minutes look much more constructive that the past week. I am not a short term trader but i was curious.
I only asked because i was watching level 2 and it hardly any volume and all of a sudden volume came in and the stock went up 20 cents.No need to get fresh !
Any MNTA news ?
Stock has just started to go up ?
First of all as a casual poster here i view this board as a 72.6 % Science board and 27.4 % Stock board . Almost all other boards have over a 50% stock marketing bias. So this may answer your first compliant.Please don't look to a scientist to explain a stocks movement .Its an oxymoron .We are hear to discuss facts first and try to translate that in to sound investing . The sole generic bill of goods is still very possible if you follow the science . The uncertainty comes from our legal system.So lets hope the law follows the science . People are human and when MNTA was shooting up to 25 the psychology of the board got tipsy.I think a post like yours in content can be very helpful to remind us that i need to wait and add in extreme pessimism and sell in extreme optimism.
Where would you put sentiment at now ?
Maybe , but the liver may not be metabolizing Vitamin D because it has been damaged .Until that damage is addressed and liver function improve supplementation may not help .
liver function is essential to providing vitamin D to the body. The liver and kidneys change vitamin D to an active form, which actually is hormonal in nature. . This is a chicken or egg question with poor Hep C response to current SOC in patients with Vitamin D deficiency that only thorough studies can answer.