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floblu14,
My quick check shows they are talking about M281 and not M254 hsIVIg.
This was the first I picked up on hsIVIg competition and I have been searching for some time.
Boing X 2
Competition?
Sounds like CW needs to get our clinical trial going at high speed. We don't want to come in second place on this drug. 11Billion plus by 2020.
For information to the board.
"http://glycot.com/pipeline/"
Boing X 2
Yeeeeeeessssss!
My updated calculation is that there are still 1,548,241 shares short and likely many more yet to cover.
I would imagine there are margin calls going out right now.
The following is still based off 5.07 million shares and not the 6/29 update.
"
Approximate Amount of Money Shorts Have Lost on the Day: $8.62 million
If Intiated on the First, Shorts Have Realized a Year to Date Return of: -71.78%
If Intiated One Month Ago, Shorts Have Realized a Return of: -5.79%
If Initiated Five Days ago, Shorts Have Realized a Return of: -12.56%
Can everyone say UGLY?
Tomorrow should be interesting. More pain? Last one out could have their lunch eaten on a gold platter. That is to say the gold they will owe their broker.
Can all say M254 clinical trial being announced shortly.
Boing X 2
funinthesun,
Correction,
Closed above 24.48 moving average.
Boing X 2
funinthsun,
Very possible.
Here is my take,
Current short position reported tonight for June 29th on NASDAQ site.
"6/29 Shares short 4,505,279"
"Breakout trade
WATCH for possible breakout above 24.83
Target: 26.54”
Total shares traded July as of tonight. 2,062,395. That is an average of 294,627 a day over 7 days. Not all these shares traded are short covering, Assume they are all short covering for a second and that leaves 2,442,894 left to be covered. That would take 8.29 days to cover assuming it was all shorts covered prior. I doubt that is the case.
Next we closed above the 50 day moving average of 22.46 which means this will be all over the radar screens tonight.
Also, we broke through the MACD to the up side. Another strong positive.
In short, I think there is a distinct possibility of a short squeeze tomorrow or very soon.
The big institutions will be seeing the same thing tonight on their radar and might force a squeeze. Good news as well could force a squeeze.
It would be nice if CW gives us the date the clinical trial on M254 starts tomorrow.
Strong looking charts
Boing X 2
biotech_researcher,
I did a quick review and don't see that involved.
Here is the report,
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm611933.pdf
Not good. Stainless steel found on pills. Yuk! Not cleaning properly, broken pills not being documented etc.
Boing X 2
New update,
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
They are still updating the patent to be ready in the future.
Boing X 2
This is a powerful study that all might want to read closely,
http://www.pnas.org/content/112/11/E1297
My words, a great unmet need. They are going off label to try and get cures on some of these bad diseases.
10 times more powerful can make a big difference if all goes well here. Prior TX did not get the right drug in a right combination.
4 to 6 hours of treatment vs. a possibly home TX.
I had not read the abstract closely until today and I was impressed on how much there is a need for this drug to come through. There is no other drug out there that can do what we might be able to do if we get approval. All thus in my interpretation of reading the abstract.
I hope MNTA bangs this big time.
Frankly, I am excited if they can pull this one off. No one else has the patents and we can take over the market with an approval and improve patient outcomes on over 84 potential diseases with future approvals.
Boing X 2
floblu14,
The article is saying 8 Billion by 2023. Not the market this year.
Boing x 2
Just found this,
"The Global Intravenous Immunoglobulin (IVIg) Market is growing at the CAGR of ~5.9% during the forecast period and expected to reach US$ 8337.2 million by 2023."
M254 has a big opportunity here with an FDA approval.
There are over 80 diseases that hsIVig can treat in the future. I saw one article this am. that said there is a lot of off label usage. That tells me due to the expense of getting each drug approved a lot of doctors might not be waiting and using it for those various diseases.
Sunday starts the second half. Let's roll.
Boing X 2
I think most are missing the boat when considering this drug.
Yep, CW said drug.
"M254 is a hyper-sialylated immunoglobulin designed as a high potency alternative
for intravenous immunoglobulin (IVIg), a therapeutic drug product that is
manufactured using pooled, human immunoglobulin G, or IgG, antibodies purified
from blood plasma. IVIg is used to treat several inflammatory diseases,
including idiopathic thrombocytopenic purpura, and chronic inflammatory
demyelinating polyneuropathy. M254 has the potential to remediate the
limitations of IVIg because sialylation of the Fc region of IgG has been seen to
augment the anti-inflammatory attributes of IVIg. We initiated an IND-enabling
toxicology study in 2017 and are targeting the initiation of an initial clinical
study in the second half of 2018. We continue to identify and explore potential
collaboration opportunities to further develop and commercialize this product
candidate.”
OK, so we have a known already approved drug that they have done sialylation of the Fc region. That made the drug up to 10 times more potent. So as I am reading it we need to find the proper dosing amounts and verify efficacy.They have already cross checked it against patient blood samples and done the toxicology study in 2017.
As CW said "it is their sleeper drug.”
Sometime after the next six days they start the phase trial. CW has already indicated he expects it to go relatively quickly.
The thing that has changed is we are not going to give away half of our profits on this potential $6 billion drug.
We are not having to re invent the wheel to get an initial drug approval here. We are seeking to show up to a 10 times improvement in a known drug.
Dosage amounts and safety as I understand. It sounds like they have given a lot of thought to this phase trial.
Boing X 2
floblu14,
Thank you.
Boing X 2
floblu14,
Thank you for the feedback.
Was there any discussion on using the same line mfg or a new one due to our prior problems?
The China mfg?
Did they discuss how they will handle sales on new approvals as if are not going to partner?
Contract sales staff?
Thank you,
Boing X 2
Yesterday GS Conference call.
All might want to listen. Too much information to post.
Research team has come up with some new drugs that they are looking at that will be discussed on analyst day in the fall.
All in all CW sounded very positive on the up coming trials and said he feels there will be no need for any more dilution.
Should hear in next 3/6 weeks on their study of all issues they have been studying.
Boing X 2
"Breakout trade
WATCH for possible breakout above 24.72
Target: 26.38”
Boing X 2
METHODS OF GLYCOPROTEIN ANALYSIS
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
Note numbers 72-79
Boing X 2
floblu14,
Good pick up on they had samples from human patients treated with IVIg to cross check their work.
That is likely why he sounds so confident.
Boin X 2
Privigen is a ready-to-use 10% liquid intravenous immunoglobulin (IVIg)
Try to get that without a prescription. You can quibble on the drug or not drug angle but it sounds like they took and changed an already approved drug, IVig, or whatever you want to call it prescription to hsIVIg. Making it 10 times more effective and have the patent on it.
That is why this it is suppose to be a fast trial. i.e. finding the right dosing amounts and hopefully few to no side affects. Right or wrong that is how I interpret what CW said on the conference recording.
Once the FDA approves it, it is a DRUG. Otherwise, they would not have to get the FDA to approve it.
Boing x 2
floblu14,
Possible we could see the 100 if the phase trial on M254 hits it out of the box.
First, as I understand it, the drug is an already approved drug. We have hypersyalated the drug and it has shown to be 10 times more powerful in animal models. That is why i suspect this is going to be a short trial. If it shows it is 10 times more powerful as in animal studies, and no side effects. BOOM. Just figure out the proper dosing amounts. If they can also show subque at the same time it is over the top.
CW said it is our sleeper program. A 4 to 6 billion market and the cost savings if they can take it to a subque shot would blow the expenses on treatment and patient suffering and lost time on patient treatments out of the park. Patients could tx at home with subdue shots. The expense saving are beyond anything we can believe if it works.
Not long to find out now. CW said, as best I can remember, they have almost reached agreement on the trail which starts the second half.
Boing X 2
Is that the best you can do?
Boing X 2
Listen to the cc and define it yourself.
You no longer own the stock so why should I waste my time on you. Too lazy to listen or just your intent to harass me? Hint, just go to the last 5 mins for an explanation.
Boing X 2
MNTA likely to partner on M254 as the potential is so big.
CW called it the sleeper program that is not going to take long to prove in phase trial starting 2nd half. All it has to do is show it is 10 times more powerful and few if any side affects.
Un met need on reduction of time to administer in a 4 Billion Dollar Market. Might show that they can even be able to do it subcutaneous. That would be big.
M281 they are also talking to the FDA to get in agreement on another rare disease with un met needs when we do the M281 trial. That second disease might get us a fast track designation.
Best take on what I heard on Merrill Lynch cc.
Breakout trade
WATCH for possible breakout above 23.04
Target: 24.54
Boing X 2
Breakout trade
WATCH for possible breakout above 22.25
Target: 23.68
"In animal models, we can reproduce and demonstrate up to 10 times the potency of IVIg. If we can do this in humans, it will be a game-changer for the IVIg marketplace, which today is a global supply constrained market with over $4 billion in sales in autoimmune indications. IVIg in autoimmune indications is a very difficult therapy for patients often requiring infusions over one or more days with challenging side effects. A drug with a fraction of the volume and infusion time and with the potential to dose higher for better efficacy could create meaningful value for patients and our investors.
We believe a single trial with a dose-ranging in normal volunteers progressing directly to patients in a population such as ITP, where IVIg is approved, could be conceded quickly, allowing us to show the benefit of this innovative compound within two years and providing another catalyst for our stocks from our promising autoimmune portfolio.''
Here is were the money will be made with approval. Note the conceded quickly. All we have to know is the trials come through. We will be the only one in the field for a long time if we get approval. Not long to wait. I hope we have a new production facility for these drugs. CW sounded totally excited when talking about the above. A drug with no serious competition is what we want. From what I heard he almost started talking about a second drug for approval at the same time and then he went quiet. I hope we hear more on the next cc.
Any Copaxone sales just helps get us to that point in the mean time. The delay hurt us and I guess the production line gets a pass for letting that happen. We are on notice for the future where we produce our drugs.
Shorts positions fell to 3.5M as of the 30th.
Note the increased in institutional buying each quarter. Scarfing up the shares,
https://www.nasdaq.com/symbol/mnta/institutional-holdings Each quarter they keep adding. First quarter being reported now.
We keep racking up patents,
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
As the little man says pointing his small finger at his chin, FOUR BILLION DOLLARS.
Boing X 2
jbog,
Last I read only the plasma is kept and the blood is returned to the patients.
Not blood letting.
Let the group come up with suggestions to avoid production problems if they don't like my ideas.
CW stated the plasma could be a problem. Figure out an action plan up front. Any plasma shortage for a multitude of reasons will be a major problem.
Just my opinion.
Boing X 2
floblu14,
How about another suggestion.
Boing X 2
Dew,
Forgot to add, their wholesale price has to be more than the 50.00 they are currently paying donors on average. The initial saving of a share for one pint has to be likely much more.
We don’t want to run into the production problems like we had on Glatopa in the future. Dedicated donors would solve that problem up front.
From what I read it takes six months to get approved as a donor. If their are any outside forces the effect collections like flu, ebola, virus or plague we might avoid supply problems in thinking ahead. We would likely be last on the supply list as the new boy on any shortage situation.
I don’t want to go through the Glatopa delay again. The fact that CW mentioned the plasma makes me concerned. We need a risk management process.
Boing X 2
Dew,
Sorry I did not mean they do the collection. From what I read many of these plasma companies have special programs.
I am just saying that would be part of a program to have our own dedicated donors. One year and they get a share of MNTA. Even if we get a discount, the potential of a share might get dedicated MNTA donors.
17 bucks a share vs. paying 50.00 would be an incentive for repeat donors. That would be an immediate profit times how many pints they need on their first donation. i.e. first donation free and one share in one year if you keep donating. You would still have the expense of the collection.
CW was concerned enough to mention that as a potential problem so I was figuring out how to avoid this problems.
You might well be right, but, he did say he was concerned.
Boing X 2
Just throwing this out there for group thinking.
As Momenta will require massive amounts of plasma for hsIVIG and other possible related drugs, and as most plasma donations likely receive 50.00 or more for a donation, I am thinking we need to get our own donor list.
Momenta figues out how many total donors they will need to meet their production needs. Obtain that many number of shares early at this cheaper price. Each donor receives one share to become part of our team. Recruit donars for MNTA products.
They must donate for at least one year to receive the one share. They stand to have appreciation of the stock as time goes on. There could be a reduced amount paid over the share for donations.
I have been reading and it is quite a process to be an approved donor. It would make sense to try and keep our overall costs down on production and hopefully have many drugs be approved.
It was mentioned on the last cc call we might have to buy our own plasma. It might make sense to recruit our own team so there is no interruption of supply due to many potential outside problems.
Concentrate donar volunteers as much as possible to keep the costs down.
Boing X 2
Just found this article. It did get my attention.
"https://www.alzforum.org/news/conference-coverage/quick-and-early-ivig-therapy-hints-promise”
hsIvig might have the potential to deliver the drug cheaper with longer lasting effects. Time might tell.
As the population ages this is becoming more of a problem and there are a ton of dollars being spent on caring for this disease.
Boing X 2
A couple of interesting articles since it appears hsIVIG is going to be the next drug produced.
"https://www.igliving.com/magazine/articles/IGL_2016-04_AR_Benefits-of-Home-IVIG-Therapy.pdf”
This one got my attention. It appears to offers all kinds of potential for MNTA to see if they can improve treatment and or survival rates on some of the diseases,
"http://www.skintherapyletter.com/dermatology/intravenous-immunoglobulin/“
Boing X 2
Yep,
She sang them both. She put on quite a show at age 73. Very talented band and back up singers.
Wife had an early am. medical procedure so we just got home.
Also, Thank you to Dew for his input.
Boing X 2
Quick post.
Listen to Barclay CC today on the MNTA website. Listen to the information about M254. Mind blowing.
Might get to market before M230. Other talk about going after untreated disease at same time on M230.
Heading to see Gladys Knight so don't have time to type more.
Boing X 2
This stock appears to be looking strong.
It goes down in the am. and then bounces back with over 1m shares.
At the end of last quarter there was a 95 per cent institutional ownership.
I await the end of this quarter institutional figures.
If the average volume is 800K shares a day something has to give.
Example 10 days is over 8 Million. There are not that many shares left.
Not saying that is the figure each day but my take is they are sucking the last shares up.
Time will tell. So if 20 days. half that amount are bought one can see the shares drying up.
First quarter and the picture should start to show with the first quarter ownership.
Just my observation.
Boing X 2
Per the CC call this am. they are going to start spending less on BioSimilars, as they have more time to market due to lengthy litigation, and spend more on novel drugs. Less litigation delays than with Biosimilars. Less competition with the novel drugs.
Glad to hear that. I have wondered why they were not considering that. Probably a lot more money to be made on being first on a novel drug.
Boing X 2
Flobu14,
Bid 17.25 offer 17.65. Should still be around 5.5M short shares. There has been 6m average since Nov. 31st. If they were thinking approval March or April they might have a problem and headache this am.
Should make for an interesting day.
Luck to all those who hung in here.
Boing X 2
Bickema,
I thought he said they would reduce the cost to us to manufacture our product due to their screw up?
Now we will be the highest cost???
Boing X 2
Friday,
Something up? Major short covering or what? Big volume.
Volume 2,216,749
Avg. Volume 845,784
Boing X 2
Pre grant patent application
MODIFIED GLYCOPROTEINS
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
rituximab
Boing X 2
Dew,
Did you notice this,
Omalizumab Xolair<®>
Boing X 2
New pre patent approval,
https://worldwide.espacenet.com/publicationDetails/claims?CC=ES&NR=2605677T3&KC=T3&FT=D&ND=3&date=20170315&DB=&locale=en_EP
This one is hard to comprehend.
https://worldwide.espacenet.com/publicationDetails/description?CC=ES&NR=2605677T3&KC=T3&FT=D&ND=3&date=20170315&DB=&locale=en_EP
If they can impact all these drugs it will be beyond comprehension.
[000125] In another embodiment, a glycoprotein is produced having reduced levels of Gal-alpha-Gal glycan structures relative to a glycoprotein in the prior art having the same or highly similar polypeptide sequence (e.g., at least 90%, 91 %, 92%, 93%, 94%, 95%, 96%o, 97%o, 98%o, 99%o identical polypeptide sequence). The method includes culturing a CHO host cell described herein that has been genetically engineered to produce reduced levels of Chinese hamster or CHO cell Ggtal relative to the parent cell (e.g., a Ggtal knock-out or knock-down CHO cell described herein), where the host cell contains a transgene encoding a therapeutic glycoprotein, and purifying the therapeutic glycoprotein from the resulting cultured cells. Such glycoproteins thus produced can provide improved versions of marketed therapeutic glycoproteins.
TABLE 5
Protein Product Reference Drug
interferon gamma- lb Actimmune<®>
alteplase; tissue plasminogen activator Activase<®>/Cathflo<®>
Recombinant antihemophilic factor Advate
human albumin Albutein<®>
laronidase Aldurazyme<®>
interferon alfa-N3, human leukocyte derived Alferon N<®>
human antihemophilic factor Alphanate<®>
virus-filtered human coagulation factor IX AlphaNine<®> SD
Alefacept; recombinant, dimeric fusion protein LFA3-Ig Amevive<®>TABLE 5
Protein Product Reference Drug bivalirudin Angiomax darbepoetin alfa ™
Aranesp bevacizumab Avastm • ™ interferon beta- la; recombinant Avonex<®> coagulation factor IX BeneFix™
Interferon beta- lb Betaseron<®>
Tositumomab Bexxar<®> antihemophilic factor Bioclate™ human growth hormone BioTropin™ botulinum toxin type A Botox<®> alemtuzumab Campath<®> acritumomab; technetium-99 labeled CEA-Scan<®> alglucerase; modified form of beta-glucocerebrosidase Ceredase<®> imiglucerase Cerezyme<®> crotalidae polyvalent immune Fab, ovine CroFab™ digoxin immune Fab, ovine DigiFab™ rasburicase Elitek<®> etanercept Enbrel<®> epoietin alfa Epogen cetuximab Erbitux™ algasidase beta Fabrazyme<®> urofollitropin Fertinex™ follitropin beta Follistim™ teriparatide Forteo<®> human somatropin GenoTropin<®> glucagon GlucaGen<®> follitropin alfa Gonal-F<®> antihemophilic factor Helixate<®>
Antihemophilic Factor; Factor XIII Hemoffl<®> insulin Humalog<®> antihemophilic factor/von WiUebrand factor complex Humate-P<®> somatotropin Humatrope<®> adalimumab HUMIRA™ human insulin Humulin<®> recombinant human hyaluronidase Hylenex™ interferon alfacon- 1 Infergen<®>TABLE 5
Protein Product Reference Drug
Eptifibatide Integrum
alpha- interferon Intron A<®>
palifermin Kepivance
anakinra Kmeret
antihemophilic factor Kogenate<®>FS
insulin glargine Lantus<®>
granulocyte macrophage colony-stimulating factor Leukine <®>/Leukine<®> Liquid lutropin alfa, for injection Luveris
OspA lipoprotein LYMErix™
ranibizumab Lucentis<®>
gemtuzumab ozogamicin Mylotarg™
galsulfase Naglazyme™
nesiritide Natrecor<®>
pegfilgrastim Neulasta™
oprelvekin Neumega<®>
filgrastim Neupogen<®>
fanolesomab NeutroSpec™ (formerly LeuTech<®>) somatropin [rDNA] Norditropin<®>/Norditropin Nordiflex<®> insulin; zinc suspension; Novolin L<®>
insulin; isophane suspension Novolin N<®>
insulin, regular; Novolin R<®>
insulin Novolin<®>
coagulation factor Vila Novo Seven<®>
somatropin Nutropin<®>
immunoglobulin intravenous Octagam<®>
PEG-L-asparaginase Oncaspar<®>
abatacept, fully human soluable fusion protein Orencia™
muromomab-CD3 Orthoclone OKT3<®>
human chorionic gonadotropin Ovidrel<®>
peginterferon alfa-2a Pegasys
pegylated version of interferon alfa-2b PEG-Intron™
Abarelix; gonadotropin-releasing hormone antagonist Plenaxis™
epoietin alfa Procrit<®>
aldesleukin Proleukin, IL-2<®>
somatrem Protropin<®>
dornase alfa Pulmozyme<®>TABLE 5
Protein Product Reference Drug
Efalizumab; selective, reversible T-cell blocker aptiva
combination of ribavirin and alpha interferon Rebetron
Interferon beta 1 a Rebif<®>
antihemophilic factor Recombinate<®> rAHF/ntihemophilic factor ReFacto<®> lepirudin Refludan<®> infliximab Remicade<®> abciximab ReoPro™ reteplase Retavase™ rituximab Rituxan™ interferon alfa-2a Roferon-A<®> somatropin Saizen<®>
synthetic porcine secretin SecreFlo™ basiliximab Simulect<®> eculizumab Soliris<®>
pegvisomant Somavert<®>
Palivizumab; recombinantly produced, humanized mAb Synagis™ thyrotropin alfa Thyrogen<®> tenecteplase TNKase™ natalizumab Tysabri<®> human immune globulin intravenous Venoglobulin- S<®> interferon alfa-nl, lymphoblastoid Wellferon<®> drotrecogin alfa Xigris™
Omalizumab Xolair<®>
daclizumab Zenapax<®> ibritumomab tiuxetan Zevalin™
Somatotropin Zorbtive™ (Serostim<®>)
[000126] Other features and advantages of the invention will be apparent from the following detailed description, and from the claims.
[000127] This invention is further illustrated by the following examples that should not be construed as limiting. The contents of all references, patents and published patent applications cited throughout this application are incorporated herein by reference.
Boing X 2