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The short-term trend, T2 is expected to rise above at least 75% in the next 1-2 months with a 90% probability hold price between $2.65 - $3.90 or more which at this current price it's a SLAM DUNK. There will be some resistance from the lines AGAIN at $1.71 and $1.57 … also volume rose on falling prices yesterday. This may be an early warning and the stock should be followed more closely … GOOD LUCK LONGS
Chinese officials say chicken wings imported from Brazil tested positive for Covid-19.
https://www.forbes.com/sites/isabeltogoh/2020/08/13/coronavirus-detected-on-batch-of-chicken-wings-imported-from-brazil-chinese-officials-say/#201523b9317c
The Vanguard Group, Inc. has recently announced that it has increased stake in T2 Biosystems Inc. (NASDAQ:TTOO) by 47.84%. After grabbing 2.2 million shares, the institutional investor is now in possession of 0.71 million shares of the Healthcare Company. The new investment brought the stake of investor firm to 1.84% having worth around $2.79 million. Moreover, Geode Capital Management LLC increased its share by 0.38 million to have a control over 0.76 million shares. And Gagnon Securities LLC raised its holdings to 0.14 million shares by acquiring 0.52 million shares or 0.43% of the stake.
This is what caused the drop asking for a extension with BARDA contract ..Hopefully they resolve it soon it's a 60 million plus contract … He should have mentioned it yesterday
08/12/20 10-Q Quarterly Filings
https://t2biosystems.gcs-web.com/sec-filings/sec-filing/10-q/0001564590-20-039633
NO BIG DEAL !!!!!!!!!
T2 reported quarterly losses of $(0.09) per share which beat the analyst consensus estimate of $(0.15) by 40 percent. This is a 74.29 percent increase over losses of $(0.35) per share from the same period last year. The company reported quarterly sales of $2.55 million which beat the analyst consensus estimate of $2.37 million by 7.68 percent. This is a 41.46 percent increase over sales of $1.80 million the same period last year.
The director also forgot to declare the guidance of revenue and earning. T2 is a potential company with lots of improvement. I heard exactly what I wanted to hear today. Having key financial figures surpass expectations only further validates that this company is moving in the right direction. The SP will follow .. GOOD LUCK LONGS
Another key takeaway from the conference call yesterday: the potential for “early victory”... which I presume means accelerated approval. Again, ARDS is a condition that happens under many circumstances, and I would expect getting off label use if necessary for all other ARDS “causes” and ultimately approval generally for ARDS would also be very likely. The notion that this is a distraction comes from yahoos who have no business giving advice. I doubt they have any relevant regulatory experience in real life.
Quote from transcript of call:
“But the way we designed the study was to build in an interim assessment our way through this study, which basically arrests on the assumptions from the data that we – from the results that we generated from our prior study. So, at less than halfway into the study, basically, we have built in a DSMB assessment, that if we see results anything close to what we saw in the last study, they might be able to declare early victory and then make a decision based on that. Okay, I am not going to give any more detail on that, because I really don’t want to go into that for competitive reasons. But I think that hopefully gives you an answer to your question less than halfway through the study, there will be an interim assessment conducted by the DSMB. They will evaluate the results. And essentially, this has done essentially so they can resize this study, but in an extreme success scenario, they might actually be able to declare early victory.”
When the primary killer in this pandemic is ARDS, and the only company with a truly viable treatment already far along in trials with excellent results is capable of providing that treatment or doing a trial, it is telling that posters who cheer on any penny stock with a nonsense trial, would be denouncing this company for doing the only thing that makes sense for them, to address the elephant in the room.
Had ATHX not addresses COVID19 ARDS the same critics would be denouncing the management and board in the same manner for “doing nothing” and would be saying it must not be ineffective if they do not want to also address this crisis. They’d be saying it was an act of sheer incompetence and a sign of likely failure that they had not quickly moved on this. I guarantee they’d be saying all manner if nasty things exactly like that. I guarantee also, in that context, the company would be broke right now, would have no chance if a accelerated trials, would not be able to advance the other trials easily because of COVID19 and would be price well below $1.
The nonsense that passes for wisdom on bulletin boards is incredible. Much of it has nothing to do with what is in the best interest of the company or shareholders. Some are jerks with an opinion, who think they know it all, and others are outright manipulators or are people with an alternative agenda.
But the notion that they should not be addressing this treatment area is, given their prior designations and trial success, absolutely idiotic. It deserves no consideration.
Now, could they have done and EUA? Yes, I think they should have. Other companies have done that and it only helped the perceptions of them. But we may not fully understand the limitations, but I think it was not ideal for them to not do it and it undermined the confidence and ability of the company to communicate effectively the pandemic noise of a thousand companies that could NEVER be treatments fir ARDS stealing the limelight. But still, I am convinced they made the choice rationally, whether I agree with it or not.
Secondly, I do think they moved fast on the trial, and I recognize they are operating by the book. That’s always good with regulators, but that’s another reason why doing the EUA would have helped drive perception and likely have created more pressure for the funding they hope for now. I think it was extreme caution, and I understand they are driving this baby down the street with extreme care. It might be reckless to do otherwise when there is so much potential here, but it might also pull the bandaid off quickly if there is nothing here.
Other than that I have no criticism of them for creating the MACOVIA trial. I think people trying to drive the buss from bulletin boards are untrustworthy critics generally because one week they will say vociferously one thing and the next the opposite thing without any self-awareness or thought. Companies do not operate that way thankfully. They actually have to be deliberate and manage the resources available to them.
Key points yesterdays conf. - BARDA package ready to go in April, stonewalled in June for all therapeutics is now under "re-review". I thought Gil sounded optimistic about chances if Congress re-funds BARDA therapies
-- Several positive mentions of negotiations with sizable European partners. Certainly did not sound like a light introductory set of conversations
-- MACOVIA still being enrolled at a lower level despite no BARDA funding; trial is built with an interim readout which could be used to adjust trial or declare victory if results are very good.
-- Stroke trial is delayed into 1H 2021 for full enrollment, YE 2021 for completion due to COVID shutdowns of locations
Overall, I liked the tone and positivity of the call. I've been in this stock 2 years and recognize that drug development is a long and winding path. Looks like we are going to back around $2.20-$2.30 Big disappointment, who knows Barda may never fund.
Chance of early news from Helios, forget it. Possible European collaboration any time soon you never know with this company.
SAME O same with lot's of talk with no accomplishment. GOOD LUCK LONGS and to Gil and his crew!
Brief run-down of upcoming catalysts and items to watch / listen in on the ER call:
- Sepsis & CV19 contracts (pending & current)
- New clients & New machine placements
- CV / Sepsis panel test sales & increase in volume around sepsis testing
- partnerships & scalability funding
- updates on the FDA side (for both CV & Lyme panels)
- New approaches to machine placement
- Any potential gov funding (BARDA updates, and CDC/HHS new funding)
- New product announcements (BARDA NextGen high throughput Machine - In Development)
- New objectives with the new BOD members
- Expenditure projections & scalability
- Changes to Tax Credits & ASC606 contract writedowns
They are ready to scale to 1m+ CV tests / month as demand requires with non-dilutive funding to get there. Lyme Panel is under FDA evaluation - CV19 has slowed this down, but should be incoming relatively soon.
Reading back the company hiring a nonpartisan lobbying group for the house of reps is very interesting.
On the G2G Consulting website, there are a couple of sections worth reading.
First, the essential guide to COVID government funding,
https://uploads-ssl.webflow.com/5552187c43c8fafa28fd470c/5ec810b826fc5672933f321c_G2Gs%20GBG%20Report%205-22-20%20Special%20Edition%20Coronavirus%20Funding.pdf
And this, which has a nice section on BARDA politics
https://www.g2gconsulting.com/updates/health
ABC .. Nicely put !! Every biotech stock that can help in Covid 19 is up anywhere from 100% to 10000%. ATHX is going to get a substantial funding deal eventually. Interesting quote from the Management team saying that you will see a biotech company that will rival AMGN in coming months to years !! The ATHX crew has been working on this shot for the past 25 years with 100 employees STRONG have been working on this shot for a quarter of century they are now ready to deliver !! GOOD LUCK LONGS
Healios released their 2nd Qtr report on Thursday. a close examination of the slides for both Stroke and ARDS shows a hand indicating the trial is very close to the end. It appears they may both close at about the same time. I speculate in about two months around October. Of note is the Sakigake note at the bottom of the "APPLY" arrow. Healios appears to tip their hand (a suttle one) on what they already know. Placing this note here at the leftmost hand side of the apply arrow indicates a speedy approval. Normally,if it is just for information purposes,that note would have been located at the middle of the apply arrow as past reports have. Although this is a double blind study, researchers can pretty much see during the patients physical behavior/movements evaluation who got the MS treatment and who did not.
Another point to consider. The PREPARATION part of the arrow is right under before the end of the ENROLLMENT arrow. This indicates that they have been preparing the PMDA approval application, perhaps almost complete except for the evaluation of the last patient or two. September completion of PMDA conditional approval is a possibility. Bottom line is, we don't have longer to wait for the results to come out and I feel confident that the results will be very good … GOOD LUCK LONGS
NICE BONUS ABOUT TO HAPPEN !! Insider gift of 45K do the math when it hits $5 a share ?
https://t2biosystems.gcs-web.com/node/10496/html
I'm reminded how easy it is to get caught up in the here and now and I'm as guilty as anyone on this board clamoring for management to seize the moment as it relates to Covid. Yes we will get a nice pop on any news of BARDA, (MACOVIA) data etc. But what is important to focus on here is (MASTERS 2) and (Treasure) the ischemic stroke trials with the following designations:
MASTERS 2 (Athersys) - enrollment ongoing
SPA, Fast Track and RMAT Designation from FDA & Positive Scientific Advice from EMA
TREASURE (Healios) - enrollment ongoing
Priority review designation from PMDA (Sakigake)
If the data proves out, this could be a life changing investment. You won't be fast enough to chase it should the trial(s) Treasure first, prove successful. What's the saying? "you gotta be in it to win it" GOOD LUCK LONGS
FDA hasnt approved any EUA since AUG 3th Usually Thursdays and Fridays approvals are announced.
(https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization).
There's ALWAYS the CALM before the storm .. GET READY !!!
This was on Reddit/Athx 3 reports that Healios announced a filing for a license to sell MS for pneumonia induced ARDS expected to be granted 1Q, 2021 with sales by the Summer of 2021. This is based on newspaper articles from Japan. The share price was reported to have risen 15%. Hopefully this is the start of many things to come .. GOOD LUCK LONGS
This was on Reddit/Athx 3 reports that Healios announced a filing for a license to sell MS for pneumonia induced ARDS expected to be granted 1Q, 2021 with sales by the Summer of 2021. This is based on newspaper articles from Japan. The share price was reported to have risen 15%. Hopefully this is the start of many things to come .. GOOD LUCK LONGS
"The T2SARS-CoV-2 Panel, run on the T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) test. This test is designed for the direct detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens in transport media from individuals with signs and symptoms of COVID-19. The Panel is commercially available and has been validated in accordance with Emergency Use Authorization requirements from the FDA. The Panel is being distributed in accordance with the FDA guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised). Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA."
Look at the Healios web site there is NEW news item on their page about financial report/results. There is a publication/slides showing that they expect the 30 patient ARDS trial and the STROKE trial to be fully enrolled by 4Q 2020. This should be good news going forward.
https://ssl4.eir-parts.net/doc/4593/tdnet/1869988/00.pdf
Three main events happened #1 TTOO is Not going to do a RS it was just a backup plan if they didn't meet compliance! Stock up 8%
#2 Earnings report Aug 11 financials should be POSITIVE which the price will be up 10%-15%
#3 EUA from FDA when and if this comes it will pop 300%-400% like all the others that haven been approved. If not approved will linger in the $2-$3 till things they are working on gain traction .. GOOD LUCK LONGS
Something is Brewing @TTOO today price action says it Allllllllllllllllllllllllll !!!
It needs to go above 1.74 this morning's pre market high 1.72
Healios will release results within one month. It means that they are shutting the gate. PPS should skyrocket above $10 or above $20 I also love Healios CEO Dr. Hardy Kagimoto’s confidence on ARDS and Covid induced ARDS that soon after data they will get either conditional or full approval. Trials in Japan should be finished as they are preparing for manufacturing ..GOOD LUCK LONGS
This is a new interview with ATHX CEO GVB. A good read for newer and prospective investors.
https://www.technologynetworks.com/cell-science/blog/progress-in-stem-cell-therapy-for-transplant-stroke-and-ards-patients-338139
This article is different which sounds much better ..
https://12bajzvm4xtfmfqi20b5icjl-wpengine.netdna-ssl.com/wp-content/uploads/2020/05/Marekovic-ECCMID-2020.pdf
This article is causes T2 to struggling .. Upside Limited Even Given Pandemic Exposure Of The Company's Diagnostic Test. I wish they would mention how many times they have been wrong. They are trying to SHAKE lose hands !!!
https://seekingalpha.com/article/4363911
News will be coming and the stock price WILL be AHEAD of the NEWS. It might take a minor break in the next few days. The stock HIGH and LOW in the range of $1.60 to $1.73 and it needs to close above $1.74 for the next run .. This a very good buying opportunity for newbies .. By the end of the year this should be trading above $10 .. GOOD LUCK LONGS
https://www.cnbc.com/2020/08/03/severe-covid-19-can-lead-to-kidney-failure-medical-studies-reveal.html
There are several ways this viral disease can make kidneys fail, Dr. Kliger notes. Some evidence shows immune systems go into overdrive and produce inflammatory cytokines, known as cytokine storms, which can hurt the kidneys as well as other organs. In other cases, biopsies have shown that the virus directly attacks the kidney by entering through ACE-2 receptors the coronavirus can hook to and then infect cells. In other cases, patients become so seriously ill from Covid-19 it can trigger sepsis, which can lead to multiple organ failure. Finally, there is also evidence that ventilators can reduce blood flow through the kidney in patients with severe lung disease due to Covid-19 and that in turn can hurt the organ.
T2 gained 1.84% yesterday rising from $1.63 to $1.66 and has now gained 3 days in a row. I think with news coming it will continue gaining or take a minor break for the next few days. During the day the stock fluctuated 8% day low at $1.60 to a day high of $1.73 .. The Volume has increased in the last day along with the price and that is a positive technical sign. T2 lies in a wide strong rising trend and this a very good buying opportunity. I think this will hold a price between $4-$6 in the next month with news coming .. JMO GOOD LUCK LONGS
T2 lies in the lower part of a very wide and strong rising trend in the short term, which poses a buying opportunity. The current short-term trend, the stock should rise above 160% in the next 1-2 months with a 85% holding a price between $4-$7 .. GOOD LUCK LONGS