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I came across a recent report that indicated the global ARDS market is 16.7 billion. This is a big increase of a global 3 billion market that I consistently saw reference to when I was first doing DD on ATHX back in 2015/2016. With MERS, SARS, COVID and Swine Flu all 21 century illnesses and all lead to ARDS in the most serious cases it is logical to conclude the ARDS market, even only a few years ago was vastly undervalued at that 3 billion number. Is it 16.7 billion? I don't know but let's split the difference and say its 9 billion which is reasonable. There is decent competition in this space now but I do believe MultiStem is at or near the top of the products in safety and efficacy so let's estimate they can get 25% market share here.
9,000,000,000 X 0.25 = 2,250,000,000 annual revenue for ARDS
Everyone is familiar with the stroke numbers. Its about a 30 billion global market and MultiStem will be the only game in town for this potentially being able to reach 90% patient population. Let's be really conservative here and say we can get 50% of the market (this is conservative in my view).
30,000,000,000 x 0.50 = 15,000,000,000 annual revenue for ischemic stroke
Trauma is insane from Athersys' own website its about 37 billion annually JUST IN THE US. I have seen estimates the global market is around 250 billion. Again let's be conservative and just use the US numbers and again MultiStem would be the only game in town but let's again say they only get 50% of US market and say rest of world is $0 right now.
37,000,000,000 x 0.50 = 18,500,000,000 annual revenue from US trauma
2,250,000,000 + 15,000,000,000 + 18,500,000,000 =35,750,000,000 / 197,600,000 shares = $180.92
Ahhh but this is 1 to 1 revenue/price ratio. Stocks trade at a premium and biotech is usually between 4-6x sales. Let's split the difference and say this will be 5x. $180.92 x 5 = $904.60
Let's be even more conservative and take out trauma altogether.
2,250,000,000 + 15,000,000,000 = 17,250,000,000 /197,600,000 = $87.30 x 5 = $436.50
Again this doesn't constitute investment advice, this is just a math exercise to demonstrate why some aren't in favor of a buyout. Anyone can put whatever variables they wish for market share, global market, etc. I was trying to be realistic and conservative using the numbers I have seen for each target market. So Gil, do not sell out for cheap! Reddit posts have already been memorialized in court documents ... GOOD LUCK LONGS
P ..Just in case you missed any of these articles ..
VANCOUVER, British Columbia, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Isracann Biosciences Inc. (CSE: IPOT) (XFRA: A2PT0E) (OTC: ISCNF) (the “Company” or “Isracann”) an Israel-based company focused on becoming a premier low cost, high quality cannabis producer is pleased to provide a year end summary of activities and outlook for 2021.
There is a sense of relief that 2020 is now behind us. Over the course of the past year, the impact of COVID-19 has been felt around the globe and will undoubtedly continue to impact countless lives and entire economies for years to come. While many difficulties remain before us all, a guarded optimism is growing daily. The challenges that directly impacted our venture were principally logistical and operational in nature and affected most of the sector equally. Given the Israeli governments increasingly pragmatic outlook regarding cannabis we remain extremely optimistic regarding our ability to achieve our strategic goals for the new year.
In consideration of the disruptive nature of the pandemic, Isracann is nonetheless extremely pleased to have made continued progress at both its domestic operations. At our early-stage Nir, Israel farm, the Company was required to realign elements of its submission to the Settlement Commissioner for the Nir region, which was expedited via the invaluable aid of our regional consultants. This process has paved the way for a formal application to the Ministry of Health. In all other respects the project is poised for fast-tracked completion with commencement of operations to occur as soon as approval is received.
The agreement and commitment to accelerate the completion of the flagship Hefer Valley-based Ein Hahoresh Farm has proven to be a key driver for the Company. With 165,000 sq. ft. of greenhouse canopy and extensive processing capability in-place, the Company and its regional partners are moving rapidly towards industrial-scale operations capable of servicing both the domestic and increasingly important European export markets in 2021.
Per recently amended regulations that require all physical facilities to be completed and approved prior to planting, the construction activities at the Ein Hahoresh farm expanded the onsite post-harvest facility in preparation for commencement of operations and increased demand from growing domestic and export markets. We are well poised to, in the short term, complete the facility and receive the required Security and Ministry of Health approvals to acquire our farm operating license and start planting. Consequently, Isracann and its local consultants are currently scheduling the commencement of planting in March to coincide with the start of optimal climatic conditions. Additionally, applications for certification of Isracann as foreign cannabis cultivation license owners were submitted to the Ministries of Security and Health, which upon acceptance, will result in Isracann’s ability to formally complete any remaining aspects of our joint venture acquisition.
While completion of our farms is the primary focus of the company, we have been actively initiating and expanding our visibility and relationships across the region and onwards into Europe. Our goal has been to establish infrastructural agreements aimed at launching Isracann onto the world stage as a truly international cannabis enterprise. As these pending activities are commercial in nature, and include multiple parties, we look forward to announcing further details outlining our expanded strategic outlook for the coming year as soon as possible.
Concurrently, the domestic legislative, regulatory, and societal environment regarding cannabis production, processing, distribution, and sales within Israel continues to improve as do the opportunities for export operations. Last year saw several landmark rulings and accelerated momentum that is rapidly transforming this emerging sector into a respected national industry.
It is also worth mentioning that Israel has been noted as an early leader in the distribution of coronavirus vaccinations, and this appears to be driving optimism for the entire business community throughout the region. Isracann and its team of professional consultants are confident this will aid initial sales projections upon entry into a domestic marketplace which is markedly more robust than ever before.
Company CEO Darryl Jones comments, “Since our decision to enter the market sector in Israel just 20 short months ago, we have seen cannabis reform, including major advances in legalization, production and distribution. We’ve also seen the door opening up for export sales, and a wholesale shift in cultural acceptance. And yet we have had to deal with some setbacks as the regional governments come to terms with new regulations and the impact of a global pandemic. But one thing to remember is that this is just the playing field, and it is the same field for everyone in the sector. As players, we have engaged top industry professionals to consult on our behalf, incorporated leading agronomic experts to show us the true path to product excellence, and ensured our leadership includes a strong mix of business and production expertise. We have a team with big league knowhow and home field advantage, and this all translates into ability and confidence. We are well positioned and well financed and are committed to ensuring that 2021 is the year Isracann gets fully into the game and starts to deliver the returns we know its capable of. With that vision firmly in-place, we thank all our supporters for your continued trust as we forge ahead to make this year an outstanding opportunity for value creation through the intelligent application of capital into predictably growth-focused areas of the global cannabis industry.”
ON BEHALF OF THE BOARD OF DIRECTORS “Darryl Jones”
Chief Executive Officer and President
About Isracann Biosciences Inc. (CSE: IPOT) (XFRA: A2PT0E) (OTC: ISCNF)
Isracann is an Israeli-based cannabis company focused on becoming a premier cannabis producer offering low-cost production targeting undersupplied, major European marketplaces. Based in Israel's agricultural sector, Isracann will leverage its development within the most experienced country in the world with respect to cannabis research. The Company has secured agreements within Israel for medicinal marijuana cultivation. For more information visit: www.isracann.com.
https://isracann.com/2021/01/11/isracann-announces-launch-of-early-warrant-exercise-incentive-program-and-repricing/
https://isracann.com/2021/02/02/isracann-prepares-to-import-canadian-cannabis-into-israel-and-europe/
It is well known that demand for cannabis in Israel exceeds supply as they are currently importing cannabis into the country, ISCNF announced that they will be importing cannabis from Canada for sale into the Israeli and European markets. This should jump start medical cannabis revenue by mid 2021. ISCNF also announced they will be ready to plant in March 2021 and with their processing facility complete, they could be market ready for sale of their home grown cannabis by late 2021. Therefore, it is reasonable to expect they could ramp revenue to $1 million a month in 2022 and the business model is very similar to IM Cannabis (CSE:IMCC, OTC:IMCNF) which is also an Israeli cannabis company. They are doing about a $1 million a month in revenue with 165 million shares outstanding. Their shares currently trade for about CDN $2.50 (USD $2.00) a share, so as a comparable, one might conclude this Co. could trade at CDN $2.50 (US $2.00) when they reach the $1 million a month milestone in 2022. As an added kicker Israel is set to legislate the approval of adult-use cannabis by the end of 2021, so this could turbo-charge revenue to drive their share price to $3 to $4 in 2022. This is a double sometime this year .. GOOD LUCK LONGS
Don't forget Investor day is Tuesday ..I expect good things out of this Conference along with some Big news. The stock price isn't acting like good news ahead but the recent moves made by Healios is probably the reason .. Suing then agreeing on a deal regarding notification of EU partnership last Friday and now this new deal with Spline on distribution in Japan strongly indicates PMDA licensing is going to happen shortly. The first thing to get licensed will be ARDS since it will help in the treatments. Partnership should come along sooner than later. Interestingly, Healios could also make a deal with ATHX in the area of Trauma. Right now Healios is not licensed to treat trauma patients with multistem which will change. GOOD LUCK LONGS
R .. Are you a Dr. or a Lab technician / day trader ?
Its starting to unravel .. GOOD LUCK LONGS
https://ssl4.eir-parts.net/doc/4593/tdnet/1927695/00.pdf
Dr Dean just covered TTOO latest news .. GOOD LUCK LONGS
ATHX agrees to provide Hardy at least 15 business day notice BEFORE entering into Partnership or before presenting such partnership to the board of directors for approval;
2. However, ATHX does NOT agree to provide the IDENTITY of the potential Partner until at least two business days before the Company intends to enter into such a transaction or present the option to the board of directors;
Note: This means that although ATHX may give notice they're entering into a partnership, they will NOT provide the identity of the Partner until two business days before entering into the partnership. To me, this means that Hardy may create a counter-proposal, but won't be able to cause issues in light of the Partner's identity.
3.Hardy commits NOT to speak with a potential partner about the partnership without acquiring APPROVAL from the ATHX board first;
Note: Likely because they don't want Hardy to screw up the transaction.
4. In light of the above, ATHX will not oppose Hardy's motion;
5. Additionally Hardy, Healios, and/or any entity associated with Hardy or Healios CANNOT interfere with ATHX's negotiation or entry of said Partnership; and
Here's the language:
"No (a) affiliate, associate, or agent of Plaintiff, (b) person or entity under the control of or acting at the direction of Plaintiff, and (c) person or entity under the control of or acting at the direction of Healios KK or any its subsidiaries, affiliates, or other related entities, may (i) directly or indirectly contact a potential Transaction partner (or any person or entity affiliated with a potential Transaction partner) without prior written consent from the Company or the Board or (ii) cause, take, authorize, or allow any action, that will or may interfere with the Company’s negotiation of a Transaction or with the Board’s review of such Transaction"
6. This order remains in effect UNTIL the resolution of the action.
Note: All bets are off after the case! To me, this means that time is of the essence DURING the case ... GOOD LUCK LONGS
Athersys is already planning to establish a manufacturing facility to complement their trusted CMO relationships with the Company Phase III trial. They also are working hard to establish an end-to-end process, which is very scalable and well controlled, so they can produce a large quantity of material. When this happens GIL will probably get the honor to ring the NASDAQ BELL sometime in the near future ... GOOD LUCK LONGS
https://www.genengnews.com/topics/bioprocessing/charting-the-future-of-stem-cell-manufacturing/
T2 Biosystems, Inc., an in vitro diagnostics company, develops diagnostic products and product candidates in the United States and internationally. Check disclaimer on the landing page. On the other hand, these other companies could drive platform strategically develop and provide better communication among medical practitioners and health care providers. This could be impressive right ... GOOD LUCK LONGS
Check here: https://prem.li/MustSee-Potential-HealthCareMarket
X .. You asked WHY we we're UP and what was posted gave you a reason NOT to ask the ??? .. NO BIG DEAL MY BAD !! Going forward the BIG pharmaceuticals have been watching the trials VERY closely and now are ready to start a BIDDING WAR before Japanese gobbles UP the whole pie .. GOOD LUCK LONGS
X ..I guess you didn't read this mornings post ...
NEWS: Hardy Trying to Acquire Court Order for ATHX to Provide Him Notice of New Partnership!!!!
I'm going through the docket right now. I'll upload the relevant documents soon. This seems HUGE. Hardy filed a motion called "Motion for Status Quo." The motion in effect seems to be a temporary injunction.
Here's the language of Hardy's Proposed Order:
"Defendant Athersys, Inc. (“Athersys”) shall not enter into or submit for Board approval any potential partnering transaction or other transaction outside the ordinary course of its business until such time as is fifteen (15) business days after providing Dr. Kagimoto with notice of its intent to do so, in writing, with copies to his counsel of record in the above-captioned action. "
Grrrr, the Court had not uploaded a public version of the motion yet. Appears that the motion is subject to the Parties' stipulated protective order. It takes a while for the entire motion to be filed or uploaded. A public version that is redacted will likely be uploaded soon.
I was able to access the [Proposed] Order, exhibits attached to the Motion for Status Quo (which are basically prior orders granting the request), and a letter from the Court setting the Motion for Hearing. The exhibits are too large to upload. There's nothing in there though that is specifically relevant to this case, other than instances where the Court has granted similar motions.
It looks like Hardy wants to be notified before Gil makes any deals, or signs a European distributor. Maybe he wants to put in his bid for the license to sell multistem in Europe. A bidding war for the license is probably happening .. GOOD LUCK LONGS
https://www.reddit.com/r/ATHX/comments/l8qodc/news_hardy_trying_to_acquire_court_order_for_athx/
Blackrock filed with the SEC and have increased their share position WELL OVER 13 million .. That's a GOOD SIGN .. GOOD LUCK LONGS
https://www.marketwatch.com/investing/stock/athx/financials/secfilings?docid=14650705
X .. I'm in for the duration UNTIL it hits DOUBLE DIGITS is what he's saying "IT'S All GOOD" he Knows how I INVEST allllllllll OR nothing .. lol
Financial and Operational Highlights ....
Preliminary unaudited fourth quarter 2020 total revenue is expected to be $7.8 million, including product revenue of $5.8 million, representing growth of 155% and 274% respectively, compared to the prior year period
Preliminary unaudited full year 2020 total revenue is expected to be $18.1 million, including product revenue of $11.7 million, representing growth of 118% and 119% respectively, compared to the prior year period
Sold 21 T2Dx® Instruments in the fourth quarter, including 19 in the U.S.
Sold 53 T2Dx Instruments in 2020, including 47 in the U.S., more than doubling the U.S. installed base in 2020
Achieved U.S. sepsis test utilization growth resulting in a fourth quarter annualized run rate of approximately $86,000 per legacy instrument and U.S. COVID test utilization growth resulting in a fourth quarter annualized run rate of approximately $265,000 per instrument sold in 2020
Unaudited cash, cash equivalents, current and long-term marketable securities, and restricted cash totaled $52.7 million as of December 31, 2020
In January 2021, the Company’s Term Loan Agreement with CRG was amended to extend the interest-only and principal payment periods to December 31, 2022, and to reduce the minimum product revenue target for the twenty-four month period beginning on January 1, 2020 .. GOOD LUCK LONGS
X .. I'm holding 75k and NOT selling until it hits $18-30 .. This morning it hit a pre market high of $3.00 .. GOOD LUCK LONGS
X ..I think a bidding war is heating up behind the scenes WHO knows it could be with Merck could be a possibility. ATHX shares could catapult to DOUBLE DIGITS when this is all over. Hopefully, there's trading halt before the PR hits the wires .. GOOD LUCK LONGS
This has NOTHING to do with SLEEPY JOE !!!!
As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020–January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).
Using methods previously described (5), CDC and FDA identified reports of suspected anaphylaxis in VAERS, the national passive surveillance (i.e., spontaneous reporting) system for monitoring adverse events after immunization (6). CDC physicians screened VAERS reports describing suspected severe allergic reactions and anaphylaxis and applied Brighton Collaboration case definition criteria for anaphylaxis* (7). After initial screening, reports with sufficient evidence to suggest anaphylaxis were followed up by collecting information from medical records and through direct outreach to health care facilities and treating health care providers, and, in some cases, vaccine recipients. Physician reviewers classified all initially identified case reports as anaphylaxis or not anaphylaxis and used clinical judgment to further categorize reports that were considered not anaphylaxis as nonanaphylaxis allergic reactions or nonallergic adverse events. Nonallergic adverse events, mostly vasovagal (e.g., fainting or the sensation of fainting) or suspected anxiety-related, were excluded from the final analyses. Anaphylaxis and nonanaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination (i.e., outside the 0–1-day risk window) were also excluded because of the difficulty in clearly attributing allergic reactions with onset later than this to vaccination.†
During December 21, 2020–January 10, 2021, the administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2,465,411 to females [61%], 1,450,966 to males [36%], and 125,019 to persons whose sex was not recorded [3%]) was reported to CDC. During the same period, reports of 1,266 (0.03%) adverse events after receipt of the first dose of Moderna COVID-19 vaccine had been submitted to VAERS. Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis, based on descriptions of signs and symptoms; 10 of these reports, all describing events in females, met the Brighton Collaboration case definition criteria for anaphylaxis (Table 1), corresponding to an initial estimated rate of 2.5 anaphylaxis cases per million first Moderna COVID-19 vaccine doses administered. The median age of persons with anaphylaxis was 47 years (range = 31–63 years). The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes); nine patients had onset within 15 minutes, and one had onset after 30 minutes (Figure). In all 10 reports, patients received epinephrine as part of initial emergency treatment; the route of administration was confirmed or presumed to be intramuscular based on the description of treatment and the clinical course of the event as documented in the VAERS report. Six patients were hospitalized (including five in intensive care, four of whom required endotracheal intubation), and four were treated in an emergency department; eight patients with follow-up information available are known to have been discharged home or had recovered at the time of report to VAERS. No deaths from anaphylaxis were reported after receipt of Moderna COVID-19 vaccine. Nine of the 10 anaphylaxis case reports included a patient history of allergies or allergic reactions, including to drugs (six), contrast media (two), and foods (one); five patients had experienced an episode of anaphylaxis in the past, none of which was associated with receipt of a vaccine (Table 2). No geographic clustering of anaphylaxis cases was observed, and the cases occurred after receipt of doses from multiple vaccine lots. At the time of this publication, despite follow-up efforts, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis in four of the initial 108 suspected cases reported.
Among the 43 cases of nonanaphylaxis allergic reaction after receipt of Moderna COVID-19 vaccination with symptom onset within the 0–1-day risk window, 26 (60%) were classified as nonserious.§ Commonly reported symptoms included pruritus, rash, itchy sensations in the mouth and throat, sensations of throat closure, and respiratory symptoms. The median patient age was 43 years (range = 22–96 years), and 39 (91%) of the reported reactions occurred in women. The median interval from vaccine receipt to symptom onset was 15 minutes (range = <1 minute–24 hours); in 30 (73%) cases, onset occurred within 30 minutes, in 11 cases, onset occurred after 30 minutes, and for two cases, time of onset was missing. For 26 (60%) case reports, a past history of allergies or allergic reactions, mostly to foods and drugs, was documented (Figure).
As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020–January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).
Using methods previously described (5), CDC and FDA identified reports of suspected anaphylaxis in VAERS, the national passive surveillance (i.e., spontaneous reporting) system for monitoring adverse events after immunization (6). CDC physicians screened VAERS reports describing suspected severe allergic reactions and anaphylaxis and applied Brighton Collaboration case definition criteria for anaphylaxis* (7). After initial screening, reports with sufficient evidence to suggest anaphylaxis were followed up by collecting information from medical records and through direct outreach to health care facilities and treating health care providers, and, in some cases, vaccine recipients. Physician reviewers classified all initially identified case reports as anaphylaxis or not anaphylaxis and used clinical judgment to further categorize reports that were considered not anaphylaxis as nonanaphylaxis allergic reactions or nonallergic adverse events. Nonallergic adverse events, mostly vasovagal (e.g., fainting or the sensation of fainting) or suspected anxiety-related, were excluded from the final analyses. Anaphylaxis and nonanaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination (i.e., outside the 0–1-day risk window) were also excluded because of the difficulty in clearly attributing allergic reactions with onset later than this to vaccination.†
During December 21, 2020–January 10, 2021, the administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2,465,411 to females [61%], 1,450,966 to males [36%], and 125,019 to persons whose sex was not recorded [3%]) was reported to CDC. During the same period, reports of 1,266 (0.03%) adverse events after receipt of the first dose of Moderna COVID-19 vaccine had been submitted to VAERS. Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis, based on descriptions of signs and symptoms; 10 of these reports, all describing events in females, met the Brighton Collaboration case definition criteria for anaphylaxis (Table 1), corresponding to an initial estimated rate of 2.5 anaphylaxis cases per million first Moderna COVID-19 vaccine doses administered. The median age of persons with anaphylaxis was 47 years (range = 31–63 years). The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes); nine patients had onset within 15 minutes, and one had onset after 30 minutes (Figure). In all 10 reports, patients received epinephrine as part of initial emergency treatment; the route of administration was confirmed or presumed to be intramuscular based on the description of treatment and the clinical course of the event as documented in the VAERS report. Six patients were hospitalized (including five in intensive care, four of whom required endotracheal intubation), and four were treated in an emergency department; eight patients with follow-up information available are known to have been discharged home or had recovered at the time of report to VAERS. No deaths from anaphylaxis were reported after receipt of Moderna COVID-19 vaccine. Nine of the 10 anaphylaxis case reports included a patient history of allergies or allergic reactions, including to drugs (six), contrast media (two), and foods (one); five patients had experienced an episode of anaphylaxis in the past, none of which was associated with receipt of a vaccine (Table 2). No geographic clustering of anaphylaxis cases was observed, and the cases occurred after receipt of doses from multiple vaccine lots. At the time of this publication, despite follow-up efforts, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis in four of the initial 108 suspected cases reported.
Among the 43 cases of nonanaphylaxis allergic reaction after receipt of Moderna COVID-19 vaccination with symptom onset within the 0–1-day risk window, 26 (60%) were classified as nonserious.§ Commonly reported symptoms included pruritus, rash, itchy sensations in the mouth and throat, sensations of throat closure, and respiratory symptoms. The median patient age was 43 years (range = 22–96 years), and 39 (91%) of the reported reactions occurred in women. The median interval from vaccine receipt to symptom onset was 15 minutes (range = <1 minute–24 hours); in 30 (73%) cases, onset occurred within 30 minutes, in 11 cases, onset occurred after 30 minutes, and for two cases, time of onset was missing. For 26 (60%) case reports, a past history of allergies or allergic reactions, mostly to foods and drugs, was documented (Figure).
More science is needed, Athersys will make the difference going forward ... GOOD LUCK LONGS
A California resident who was vaccinated against COVID-19 died just hours later — and authorities are trying to find out why. The Placer County Sheriff’s Office announced the death and the investigation Saturday in a Facebook post, but gave few details. The county, which is in the greater Sacramento area, was “recently notified” of the person’s death, the police said. The person had tested positive for coronavirus in December and had been vaccinated just hours before their Jan. 21 death. There was no indication which vaccine the person had been given. “There are multiple local, state, and federal agencies actively investigating this case; any reports surrounding the cause of death are premature, pending the outcome of the investigation. Our thoughts are with the family of the deceased,” the sheriff’s office wrote.
An autopsy would be done Monday, the sheriff’s office told CBS’ Sacramento affiliate.
X ..It should be MultiStem since it has significant potential to improve outcomes for patients suffering from stroke and ARDS ..Multistem market is going to be HUGE which should send ATHX to double digits .. GOOD LUCK LONGS
Take a look at T2 Last Year's R&D Setup Morphing Into Leading 2021 Growth Pick .. GOOD LUCK LONGS
https://seekingalpha.com/article/4399367-t2-biosystems-last-years-r-and-d-setup-morphing-leading-2021-growth-pick
X .. Not enough info to share, Hardy sits on the board and probably asking A LOT of questions and NOT receiving enough feedback .. Gilly seems to be the problem sharing and Hardy has no urgency to show his hand as he wants Healios to acquire ATHX on the cheap, especially with his newly formed investment group. They probably have a bidding war behind the scenes and Healios is the #1 front runner but big pharmaceuticals want a piece of this too. ATHX has Multi Billion dollar blockbuster therapies coming to market
which should be right around the corner. The focus will be manufacturing and commercialization in matter of days or weeks in Japan followed by USA ... GOOD LUCK LONGS
ATHX has Multi Billion dollar blockbuster therapies coming to market in matter of weeks or months in Japan followed by USA ..
1: ARDS which is all over worldwide news right now, due to the Pandemic of Covid induced ARDS. Athersys Japanese partner Healios final patients enrollment in few more days followed by Pivotal Binary Data and PMDA approval = MULTISTEM Multi Billion revenues.
2. STROKE: # 1 killer worldwide pre Covid Pandemic = Japanese partner Healios final enrollment almost complete followed by Binary data = PMDA approval $10 billion global stroke market.
GOOD LUCK LONGS !!!!!