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Awesome!
The fact that the FDA allowed them to skip past phase II speaks volumes. They must already know it is effective to go to phase III as that is the purpose of having a phase II study. I don’t know where to find the studies in Asia but I bet there have been some that have established efficacy. I would also speculate that the use of Bucillamine could also be a reason why they have a lower mortality rate in Asia.
If anyone knows how to research clinical trials in Asia, please do.
“(b) Phase 2. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.21#:~:text=Phase%202%20includes%20the%20controlled%20clinical%20studies%20conducted,side%20effects%20and%20risks%20associated%20with%20the%20drug.
The Spanish Flu killed millions and forced governments to soften their stance and negotiate an end to world war one. You are right. This will happen again. Pandemics are naturally occuring and there will be another to contend with. Hopefully not soon and hopefully not deadly.
A very good point. The only thing I can think of that would allow skipping phase II is if there has already been a verifiable and strong study in another country establishing proof of concept. Since this drug has been in use for decades in parts of Asia, I am speculating that they had some success managing inflammation in the lungs so there may have already been some studies establishing some efficacy.
***The FDA got a black eye for issuing the Emergency Use Authorization (EUA) for hydroxychloroquine based on anecdotes and weak studies so I don’t think they would make essentially the same mistake again by skipping phase II and not establishing proof of concept.
I don’t know where to research clinical trials in the other countries and I certainly can’t read or write in the other languages, so if anyone can and has some time to do so, it would be GREATLY appreciated.
Lastly, I am speculating again that these countries in Asia may have had significantly better outcomes so far due in part to this drug.
Outstanding news! Being able to give covid the 1-2 punch should resolve the pandemic and make some good dough along the way.
Can someone translate?
Good morning and happy Friday!
I never left just watching from afar. My position is so small that I don’t need to watch this regularly... lunch money.
Anyway, I remain very optimistic and sincerely hope that they make it to market to help those who suffer from liver disease. I’ve personally seen the impact it has on patients and their families.
BioVie Completes Patient Enrollment for its Phase 2a Clinical Trial of BIV201 in Refractory Ascites?
February 06, 2019 08:00 ET | Source: BioVie Inc.
LOS ANGELES, Feb. 06, 2019 (GLOBE NEWSWIRE) -- BioVie Inc. (OTCQB: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for liver disease, announced today that it has completed enrollment in a Phase 2a open-label clinical study of BIV201 (continuous infusion terlipressin) in patients with refractory ascites due to advanced liver cirrhosis. The Company’s novel drug candidate BIV201 has Orphan drug designations for both ascites and hepatorenal syndrome (HRS), FDA Fast Track status, and US patent protection.
“We are pleased to have achieved this important clinical milestone as we continue to develop BIV201 for patients with refractory ascites who are at high risk of deadly complications,” stated BioVie Chief Medical Officer Patrick Yeramian, MD. “What we have learned from this initial study is informing our next clinical trial design. The results will be presented to the FDA in the first half of 2019 and we expect to receive guidance on the BIV201 clinical development plan.”
This mid-stage (Phase 2a) study was designed to assess the safety and tolerability of continuous infusion of terlipressin for 28 days in cirrhotic patients with refractory ascites, and to determine the pharmacokinetics of terlipressin and its active metabolites when administered by continuous low-dose infusion in these patients. Additionally, the trial assessed reduction in ascites fluid accumulation and improvement in renal function as potential indicators of efficacy with BIV201 treatment.
About BIV201
BIV201 (continuous infusion terlipressin) represents a potential new treatment option for patients suffering from ascites, HRS, and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. There are no approved drugs in the US specifically for treating ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. In addition to Orphan Drug designations for ascites and HRS, BIV201 has FDA Fast Track status and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.
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INTERESTING
BioVie Reviews Key Accomplishments in 2017 and Updates on Phase 2a Clinical Trial Progress
BEVERLY, MA--(Marketwired - January 16, 2018) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the development and commercialization of innovative drug therapies for liver disease, today reviewed key milestones achieved over the past year and provided a general update on the progress of its mid-stage (Phase 2a) clinical trial of BIV201 in refractory ascites patients.
"We made excellent progress in 2017," commented CEO Jonathan Adams. "We began the year without an investigational new drug (IND) clearance, which occurred in April. Next we obtained Institutional Review Board (IRB) approval to conduct a Phase 2a clinical trial at the McGuire Research Institute in Richmond, VA, and by November had treated our first two refractory ascites patient with Orphan drug candidate BIV201. In May, our core US patent covering the treatment ascites due to liver cirrhosis was issued by the US Patent & Trademark Office, and the Company subsequently filed for patent protection in Japan and China. In December we secured FDA Fast Track status."
To date, two refractory ascites patients have been treated in the Phase 2a open-label clinical trial of BIV201 of the 6 total patients to be enrolled. While no conclusions can be drawn from only two subjects, both patients indicated evidence of response on certain efficacy measures. Refractory ascites patients are extremely ill with a very poor quality of life. They have frequent hospitalizations due to disease complications and a mortality rate of approximately 50% at 6 to 12 months. Both patients in the BIV201 trial experienced medical complications, but the drug itself (continuous infusion terlipressin) was well tolerated. After reviewing the results, the Data and Safety Monitoring Board (DSMB) supported continuing the clinical study.
The results for all 6 refractory ascites patients planned for BioVie's Phase 2a clinical trial of BIV201 are expected by the second quarter of 2018. In addition to evaluating the safety of BIV201 therapy, the study will examine indicators of efficacy, including reduction in ascites fluid volume and the need for paracentesis procedures (the mechanical withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091). The safety and efficacy of BIV201 (continuous infusion terlipressin) as a treatment have not been established with the FDA.
About BIV201
The Company's new drug candidate, BIV201, has Orphan-drug designation and US patent protection, and represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically indicated for the treatment of ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. BioVie has applied for additional Orphan-drug designations for other life-threatening conditions associated with advanced liver cirrhosis.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for the treatment of ascites, an estimated 40% of patients die within two years of initial diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US medical costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. For more information about BioVie, please visit our website: www.biovieinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its Phase 2a clinical trial.
CONTACT INFORMATION:
BioVie Inc.
info@biovieinc.com
Copyright © 2018 BioVie Inc, All rights reserved.
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BioVie Announces Second Patient Dosed with BIV201 in Phase 2a Clinical Trial; First Patient Completes 28-day Treatment Regimen
BEVERLY, MA--(Marketwired - November 08, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, reported today that a second patient has been dosed with the Orphan drug candidate BIV201 (continuous infusion terlipressin) in a mid-stage Phase 2a clinical trial of patients suffering from refractory ascites due to advanced liver cirrhosis. This study is designed to evaluate a total of 6 patients with refractory ascites. Last month the first patient completed 28 days of treatment with BIV201 and entered the post-therapy observational period.
"We are pleased with the progress and grateful to Dr. Jasmohan Bajaj, our Principal Investigator, and to the medical staff at the McGuire Research Institute for conducting the trial so effectively," said Patrick Yeramian MD, Medical Director for BioVie. Jonathan Adams, CEO, commented, "Chronic liver cirrhosis primarily due to hepatitis, alcoholism, and increasingly non-alcoholic steatohepatitis (NASH) causes complications that claim thousands of American lives each year. These patients have a very poor quality of life and are frequently hospitalized. Our team, working with worldwide leaders in liver disease, is dedicated to addressing this problem."
The Company's open-label, prospective, mid-stage (Phase 2a) clinical study is being conducted in ascites patients who are refractory to, or intolerant of, diuretic therapy. It will take an estimated 6 to 9 months to complete. In addition to evaluating the safety of BIV201 therapy, the trial will examine indicators of potential efficacy, including the degree of ascites fluid generation and the need for paracentesis procedures (the withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091). The safety and efficacy of BIV201 (continuous infusion terlipressin) as a treatment have not been established with the U.S. Food and Drug Administration (FDA).
About BIV201
BioVie Inc. began a mid-stage (Phase 2a) clinical trial with its lead candidate BIV201 in September 2017 at the McGuire Research Institute in Richmond, Virginia. This new drug candidate, which has Orphan-drug designation and US patent protection, represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically indicated for the treatment of ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. BioVie has applied for additional Orphan-drug designations for life-threatening diseases associated with advanced liver cirrhosis.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for the treatment of ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies for liver disease. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. For more information about BioVie, please visit our website: www.biovieinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its Phase 2a clinical trial.
CONTACT INFORMATION:
BioVie Inc.
info@biovieinc.com
Copyright © 2017 BioVie Inc, All rights reserved.
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BioVie Inc
100 CUMMINGS CENTER, SUITE 247-CBEVERLY, MA 01915
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Michael Sherman Joins BioVie Board of Directors and Purchases Company Stock
BEVERLY, MA--(Marketwired - October 25, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today welcomed Michael Sherman, a highly accomplished financial industry executive, to its Board of Directors as an independent director. In addition, Mr. Sherman purchased common shares of BioVie stock through a private placement.
Mr. Sherman is currently on leave as a Managing Director at Barclays Plc, where he has worked since 2008. Prior to this position, Mr. Sherman was a Managing Director at Lehman Brothers, Inc. He has worked in finance for 30 years, having begun as a securities lawyer in New York and having served as an investment banker at Salomon Brothers, Lehman Brothers, and Barclays. Mr. Sherman has significant experience in healthcare finance, most recently assisting on a $450 million convertible deal for Neurocrine Biosciences. He has worked on successful financial transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck & Co., and Cardinal Health, among other companies. After graduating from the University of Pennsylvania, Mr. Sherman received his JD, cum laude, from the Harvard Law School.
"Michael has decided to leverage a successful career in investment banking to help companies grow and develop," said Jonathan Adams, CEO. "We are very pleased that he's joining our team and will contribute his extensive financial, legal, and deal-making skills to BioVie."
Mr. Sherman is replacing Ms. Amrit Shahzad on the Company's Board of Directors. Ms. Shahzad is stepping down after 3 years of service to BioVie and its predecessor company. "It has been a real pleasure working with Amrit, who has used her medical and biopharma industry background to make numerous important contributions to the Company. We're glad that she will continue to assist BioVie on an informal basis. On behalf of our team members and shareholders -- thank you Amrit!"
BioVie is currently conducting a mid-stage (Phase 2a) clinical trial of the Orphan drug candidate BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no FDA-approved drugs specifically for treating ascites.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies for liver disease. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. For more information about BioVie, please visit our website: www.biovieinc.com.
About BIV201
BioVie Inc. began a Phase 2a clinical trial with its lead candidate BIV201 in September 2017 at the McGuire Research Institute in Richmond, Virginia. This new drug candidate, which has Orphan-drug designation and US patent protection, represents a potential treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. More information about the trial may be found at clinicaltrials.gov, identifier: NCT03107091. The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for the treatment of ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. BioVie has applied for additional Orphan-drug designations for life-threatening diseases associated with advanced liver cirrhosis.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its Phase 2a clinical trial.
CONTACT INFORMATION:
BioVie Inc.
info@biovieinc.com
Copyright © 2017 BioVie Inc, All rights reserved.
Thanks for subscribing to our alerts!
Our mailing address is:
BioVie Inc
100 CUMMINGS CENTER, SUITE 247-CBEVERLY, MA 01915
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No shares are ever traded. LMAO. You need to let sleeping dogs lie.
Make up your mind. Also, you ain't fooling anyone. Stop trying to manipulate this stock.
A thief has arrived.
Thank you. You have the best timing :)
BioVie Announces Issuance of US Patent Covering BIV201 for the Treatment of Ascites Due to Liver Cirrhosis
BEVERLY, MA--(Marketwired - May 24, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today announced that the US Patent and Trademark Office (USPTO) has issued US Patent No. 9,655,945 covering the Company's new drug candidate BIV201 in development for the treatment of ascites in patients with advanced liver cirrhosis.
BioVie's medical advisor Paolo Angeli, MD, and Company personnel pioneered this potential new therapeutic approach. The patent is supported by clinical data generated by Dr. Angeli and licensed exclusively to the Company by the University of Padova, Italy. It is assigned to BioVie and will provide patent exclusivity in the US under the issued claims through 2036.
"Dr. Angeli is deeply committed to improving medical therapy for these desperately ill patients and it has been our privilege to work with him," commented Jonathan Adams, BioVie CEO. "This newly-issued patent provides strong intellectual property protection for our lead therapeutic candidate BIV201. It positions BioVie as the emerging leader in developing a new drug therapy for ascites and potentially other deadly complications of advanced liver cirrhosis." BIV201 could become the first drug ever approved by the FDA for treating refractory ascites due to liver cirrhosis, a life-threatening condition which affects about 10,000 Americans.
BIV201, which has Orphan drug status, is a continuous infusion of the peptide terlipressin. It will soon commence a Phase 2a trial in 6 patients with liver cirrhosis and ascites who are refractory to, or intolerant of, diuretic therapy and require large-volume paracentesis (withdrawal of >4 liters of ascites fluid with a large-bore needle). Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no drugs approved by the FDA specifically to treat ascites.
US Patent No. 9,655,945 may be viewed on the USPTO website. More information about the Company's planned Phase 2a clinical trial may be found at clinicaltrials.gov. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the completion or success of its planned Phase 2a clinical trial.
CONTACT INFORMATION:
BioVie Inc.
info@biovieinc.com
Copyright © 2017 BioVie Inc, All rights reserved.
Thanks for subscribing to our alerts!
Our mailing address is:
BioVie Inc
100 CUMMINGS CENTER, SUITE 247-CBEVERLY, MA 01915
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Distinguished BioPharma Executive Hari Kumar Joins BioVie Board of Directors and Purchases Company Stock
BEVERLY, MA--(Marketwired - May 10, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today welcomed Dr. Hari Kumar, a highly accomplished biopharmaceutical industry executive, to its Board of Directors as an independent director. In addition, Dr. Kumar purchased common shares of BioVie stock through a private placement.
After earning a PhD in immunology in 1984, Dr. Kumar embarked upon a successful career in the biopharmaceutical industry. He held positions of increasing responsibility at Roche Pharma culminating in serving as Global Business Development Director, and in 2007 assumed the role of Chief Business Officer for Amira Pharmaceuticals. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million. He then served as Chief Executive Officer (CEO) for Panmira Pharmaceuticals LLC, which is developing anti-inflammatory compounds, and in 2013 became CEO for Adheron Therapeutics, which Roche Pharma acquired in 2015 for $580 million. Beyond his impressive track record, Dr. Kumar brings deep experience in fibrotic and liver diseases to the Company.
"We are very pleased that Hari is joining our team," said BioVie CEO Jonathan Adams. "He has expertise in our therapeutic area and will contribute to planning the clinical development of our Orphan Drug candidate BIV201, which is about to enter a Phase 2 clinical trial. On a strategic level he will assist with seeking to build substantial company value. His enthusiasm for BioVie was apparent from our first discussion about four months ago."
Dr. Kumar commented: "Speaking with the Company's core team members, including their preeminent medical advisor Guadalupe Garcia-Tsao MD, reinforced my opinion that BIV201 has the potential to become an important medical breakthrough for patients at risk of life-threatening complications due to advanced liver cirrhosis. I look forward to working with the team at BioVie to pursue success for this potential new therapy and for the overall company."
BIV201 is a continuous infusion of the peptide terlipressin, initially being developed by BioVie for the treatment of refractory ascites. It will soon commence a Phase 2a trial in 6 patients with liver cirrhosis and ascites refractory to, or intolerant of, diuretic therapy requiring large-volume paracentesis. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no FDA-approved drugs specifically for treating ascites. More information about the trial may be found at clinicaltrials.gov, identifier: NCT03107091.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the completion or success of its planned Phase 2a clinical trial.
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Thanks! Moving right along :)
BioVie Receives FDA Clearance of IND Application for Phase 2a Clinical Trial in Refractory Ascites Patients
BEVERLY, MA--(Marketwired - April 03, 2017) - BioVie Inc. (BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce that it has received notice from the US Food and Drug Administration (FDA) that the planned Phase 2a clinical trial of its new drug candidate BIV201 may be initiated. This was based on the Company's Investigational New Drug Application (IND) to conduct a study in patients with refractory or intractable ascites due to advanced liver cirrhosis.
A second key milestone was achieved when BioVie was notified by the US Patent and Trademark Office (USPTO) that its application for a core patent covering the use of BIV201 to reduce ascites formation in ambulatory patients has been allowed. This application was based on proprietary ascites patient data provided by the Company's medical advisor Paolo Angeli, MD, a leading global expert in this field, and licensed from the University of Padova, Italy, where he practices medicine. The US patent is expected to issue within 45 days at which time more details will be reported. The Company continues to pursue patent issuances in Japan, China, and possibly European and other countries.
Additionally, BioVie is pleased to announce that it has met all of the conditions needed to commence the previously announced $12 million common stock purchase agreement with Aspire Capital Fund, LLC. Any funding received under the Aspire agreement will help to support the start of the Phase 2a clinical trial mentioned above and be used for general corporate purposes.
"These represent three major advances for the Company and strongly support the BIV201 clinical development program," commented BioVie CEO Jonathan Adams. "They're the culmination of many months of effort by our IND and management teams. We are excited about taking the next steps as our compound enters the clinic. Although the primary focus will be on safety and pharmacokinetics, we are also hoping to see signs of disease improvement in severely ill ascites patients."
The Phase 2a clinical trial will consist of a small number of patients in an open-label study at a single US-based medical center, and is expected to take about 8 months. Eligible patients will have cirrhosis with ascites requiring large-volume paracentesis who are refractory to or unable to tolerate diuretic therapy. Pending the outcome of this first study, BioVie plans to follow with a larger placebo-controlled Phase 2 study.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the completion or success of its planned Phase 2a clinical trial.
Copyright © 2017 BioVie Inc, All rights reserved.
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Absolutely disgusting. The criminals are like fleas that hop around from one host to the next.
Thanks! I found the email but I appreciate everyone's efforts to keep me informed.
Interesting. Thanks! Any links?
Accomplished Healthcare Executive Jim Lang Invests and Joins BioVie's Board of Directors
BEVERLY, MA--(Marketwired - December 07, 2016) - BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Mr. James Lang as an independent member of the Company's Board of Directors. Mr. Lang is an active investor in emerging healthcare companies, and recently invested in BioVie.
Mr. Lang was formerly the Chief Executive Officer of Decision Resources Group (DRG), a leading healthcare research and consulting company. During his tenure there, Mr. Lang helped to transform the company into an industry leader, achieving robust revenue and profit growth. Previously Mr. Lang was the CEO of Strategic Decisions Group, a premier global strategy consultancy, where he expanded the life sciences practice and later sold it to IMS Health. He brings a highly relevant experience base, having invested in and guided the development of multiple early-stage healthcare companies including Boston Heart Diagnostics, which sold for $140 million, and AlphalmpactRx, which sold to IMS health earlier this year.
"Jim is an exceptionally talented businessman with a track record of building successful companies," said Jonathan Adams, BioVie CEO. "He is also enthusiastic about our new drug candidate BIV201, for which we recently submitted an IND application to begin clinical trials." Mr. Lang commented: "This is an exciting opportunity at this time, and the company is targeting an attractive and underserved space. I've known Jonathan and [BioVie board member] Cuong Do for many years, and I'm very confident in their capabilities."
BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. This new drug candidate has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drugs specifically to treat this condition.
BioVie submitted an Investigational New Drug (IND) application to the FDA for its lead therapeutic candidate BIV201 in November, 2016. The Company anticipates commencing a mid-stage (Phase 1b) clinical trial in US ascites patients in early 2017. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In November 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company's new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in early 2017.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot assure that the FDA will accept the BIV201 IND filing.
Copyright © 2016 BioVie Inc, All rights reserved.
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In all fairness, there isn't much to read into this. There is no volume to do anything and its trading at a low PPS. BUT maybe it is a vote of confidence... who knows.
INTERESTING.
Thanks for the heads up! Seems to me we are getting ready to get into 1st gear.
Yes interesting but I would not read too much into that... We just don't know enough about anything here.
Based on ihub streamer Nano has 10x more volume today than CTIX!!! Gonna be a crazy day.
Thanks!
Samsung Executive Cuong Do Joins the Company as Independent Board Member
BEVERLY, MA--(Marketwired - May 03, 2016) - NanoAntibiotics, Inc. (OTCQB: NNAB) (the "Company," soon to be known as BioVie Inc.), a development stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today the appointment of Cuong Do, MBA, as an independent member of the Company's Board of Directors. Mr. Do is currently Executive Vice President, Global Strategy Group for Samsung, where he helps to set the strategic direction for Samsung Group's diverse business portfolio.
As the former Chief Strategy Officer for Merck, a leading US pharmaceuticals company, and having successfully built and sold a biotechnology company, Mr. Do brings highly relevant experience to NanoAntibiotics (BioVie). Prior to Merck he was a senior partner at McKinsey & Company, where over 17 years he helped build the healthcare, high tech and corporate finance practices. Mr. Do holds an MBA from the Tuck School of Business at Dartmouth.
"Cuong is very impressive, as evident years ago when we attended business school together and more recently when he acted as an advisor and investor in LAT Pharma LLC (recently acquired by NanoAntibiotics). He brings remarkable business acumen and corporate strategy expertise to the Company," commented Jonathan Adams, MBA, CEO of the Company. "Cuong is committed to advancing our CIP Terlipressin Technology for the benefit of desperately ill patients, and to creating substantial value for our shareholders."
The Company's goal is to commence a clinical trial program as early as 2017 upon FDA acceptance of an Investigational New Drug ("IND") application, currently being developed.
About Liver Cirrhosis and Ascites
About 1 million Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th leading cause of death due to disease in the US, killing an estimated 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity.
Ascites is a common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity. With no medications approved by the FDA specifically for treating ascites, the prognosis for these patients is very poor, with an estimated 40% of patients dying within two years of diagnosis. Life-threatening complications of ascites include infection, sepsis, and circulatory dysfunction. Certain drugs approved for other uses may provide relief in the initial stages, but as ascites worsens, patients may fail to respond to drug therapy. This represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About NanoAntibiotics (BioVie)
NanoAntibiotics, Inc. (soon to be known as BioVie Inc.) is a development stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing CIP Terlipressin Technology, a novel approach to the treatment of ascites due to liver cirrhosis, acquired through the acquisition of LAT Pharma LLC. In early 2016 the Company held a pre-investigational new drug ("pre-IND") meeting with the FDA, which provided guidance for an IND submission. The Company's new drug candidate could potentially commence US clinical trials as early as 2017. Additionally, NanoAntibiotics has a collaboration with PharmaIN Corporation (Bothell, WA) to develop novel compounds targeting severe complications of liver disease.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause NanoAntibiotics' actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. NanoAntiobiotics has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are NanoAntibiotics' need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact that NanoAntibiotics' compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in NanoAntibiotics' filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. NanoAntibiotics undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Copyright © 2016 NanoAntibiotics, Inc., All rights reserved.
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WTF??? Who sold! Shaving it to ten-thousandths! Disgusting.
Miles, what gives??? Why was I censored? Its beyond explanation and leads to serious credibility issues here.
Why was my post deleted? Anyone????
Also, no volume for months and now we get a $34 trade???
"Each of those 53512 represents 100 shares."
INTERESTING indeed.
Well, I think I read over the weekend that there were fewer than 35 registered investors. If so, the few of us are holding tight to see what develops. Afterall, it was just above a nickle last week.
Wow! Totally out of left field. Now I have to spend a few hours this weekend researching and digging in! Thank you for the heads up!
Dips. Always dips.
Someconcerns, please make decisions based on your research. My assessment of Nano is purely based on what I've seen transpire at CTIX since spring of 2011. There is more than meets the eye here but too early to tell and no way to tell.
If by chance there is a possible collaboration with ctix and nano antibiotics it can pop up at anytime. If CTIX gets baugh out and I'm right about some sort of reinvestment taking place here or some sort of transfer of pipeline from ctix to nano you can expect that to happen not too long after the sale is announced.
***of course this is all speculation and nano could be working on something totally different. Good luck to you and please do not become a bad guy.