The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )
- Thread starter Tug life
- Start date
Tug life
I stay fly like a guillemot
Yahoo is now part of Verizon Media
CorMedix Approved to Sell $5.5 Million of NOL Tax Benefits Through the New Jersey Economic Development Authority Program
February 3, 2020, 4:19 PM EST
BERKELEY HEIGHTS, N.J., Feb. 03, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer approximately $5.5 million of the total $6.0 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s application to participate in the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2019. The Company anticipates receiving approximately $5.2 million in cash proceeds from the sale of its NOLs during the first quarter of 2020. Closing is subject to NJEDA’s typical closing conditions, which are in process.
“We are pleased to receive a significant allocation from this program for the second consecutive year,” said Khoso Baluch, CorMedix President & CEO. “The funding will help us make preparations for an anticipated commercial launch of Neutrolin® in the U.S. market. The Company is planning for a potential approval of a new drug application for Neutrolin during the second half of 2020.”
CorMedix Approved to Sell $5.5 Million of NOL Tax Benefits Through the New Jersey Economic Development Authority Program
February 3, 2020, 4:19 PM ESTBERKELEY HEIGHTS, N.J., Feb. 03, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer approximately $5.5 million of the total $6.0 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s application to participate in the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2019. The Company anticipates receiving approximately $5.2 million in cash proceeds from the sale of its NOLs during the first quarter of 2020. Closing is subject to NJEDA’s typical closing conditions, which are in process.
“We are pleased to receive a significant allocation from this program for the second consecutive year,” said Khoso Baluch, CorMedix President & CEO. “The funding will help us make preparations for an anticipated commercial launch of Neutrolin® in the U.S. market. The Company is planning for a potential approval of a new drug application for Neutrolin during the second half of 2020.”
Tug life
I stay fly like a guillemot
Yes finally, I've been in since 2018 they will either be approved or denied the second half of the year. I'm super confident they will get approved because everything is going as planned.
NEW YORK and TORONTO, Feb. 06, 2020 (GLOBE NEWSWIRE) -- NexTech AR Solutions (the “Company” or “NexTech”) (NEXCF) (CSE:NTAR) (N29.F), the industry leader in augmented reality, is pleased to announce that it has achieved record revenue and gross profit for the month of January 2020. Both revenue and gross profit showed dramatic increases in January. Notably, the company achieved $800,000 in revenue and gross profit of $528,000 representing a 66% Gross profit versus a 59% gross profit last month and the highest revenue ever achieved in a single month, which represents a 110% increase in revenue and 172% increase in gross profits year over year.
Yahoo is now part of Verizon Media
Revenue over the last 3 months:
Nov: $700K
Dec: $760K
Jan: $800K
Should be over $1M in Rev Per month round July/Aug, if not before.
SP has taken a hit over the last few days, but thats a buying opp for some.
GL
CytoDyn Inc (OTCMKTS:CYDY), a late-stage biotechnology company, said Thursday that it has filed a Phase 2 protocol for a basket trial with its lead drug leronlimab for treating all solid cancer tumors with the US Food and Drug Administration (FDA) under its cancer investigational new drug (IND) program. In a statement, the Vancouver, Washington-based company said it can immediately initiate enrollment in the Phase 2 clinical trial for the treatment of 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, breast, testicular, ovarian, uterine, pancreas, bladder, and colon carcinoma among other indications.
I just gave this another listen. Something that I totally missed last time...
They are planning on releasing some kind of volumetric entertainment play in episode form by the end of this year.
So, if Im thinking about this correctly, this will basically be that technology (w/o interacting) they used in Black Panther before BP attacked that convoy.
Oppenheimer Asset Management Inc. reports 30.20% increase in ownership of AMRN / Amarin Corp. Plc
February 07, 2020 - Oppenheimer Asset Management Inc. has filed a 13F-HR form disclosing ownership of 14,667 shares of Amarin Corp. Plc (NASDAQ:AMRN) with total holdings valued at $314,000 USD as of December 31, 2019. Oppenheimer Asset Management Inc. had filed a previous 13F-HR on October 31, 2019 disclosing 11,265 shares of Amarin Corp. Plc at a value of $171,000 USD. This represents a change in shares of 30.20 percent and a change in value of 83.63 percent during the quarter.
BaldingSoHard
Veteran
This year's speculative investment is gonna be $RCEL.
Ya'll remember this video from 2010? Well the technology was FDA approved in 2018. This is the first-to-market application.
They've got product moving out to burn units all over the country.
542% revenue growth YoY.
I'm long at $9.68
Ya'll remember this video from 2010? Well the technology was FDA approved in 2018. This is the first-to-market application.
They've got product moving out to burn units all over the country.
542% revenue growth YoY.
I'm long at $9.68
BaldingSoHard
Veteran
Yup. It's a game-changer. I remember reading about a study where they were studying the effects of an experimental skin gun vs traditional skin grafts on different groups of patients. Halfway through the study, the doctors (not the scientists conducting the study) shut it down because they (the doctors treating the patients) decided that not treating patients with the skin gun exclusively was unethical. Of course I can't find the link now.
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I'll jump into it. Thanks breh
ACST filled a form 6-K
LAVAL, Quebec, Feb. 10, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, or HTG (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that a detailed examination of the Phase 3 TRILOGY 1 results for CaPre is underway, including specific clinical site audits and an audit of the central testing laboratory.
As previously reported, the Company noted a highly unusual placebo response in its topline triglyceride reduction primary endpoint, far greater than seen in any prior omega-3 triglyceride lowering trials, with 5 sites out of the total 54 enrolling sites disproportionately contributing to this placebo response. These sites accounted for about 36% of the 242 patients enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was conducted at 71 sites in Canada, Mexico and the United States that enrolled a total of 278 patients. The 5 sites also participated in TRILOGY 2, however these sites accounted for only 12% of the total patients, with the majority of these patients coming from only 3 sites.
Despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and identify protocol violations, the Company has subsequently identified some unexpected and inconsistent findings that it believes may have negatively contributed to the overall topline results. These findings are now being further explored via a comprehensive and rigorous review of data and patient medical records by an independent team of auditors. To support this effort, the Company, its independent Clinical Research Organization (CRO) that conducted the TRILOGY studies, its principal investigator Dr. Mozaffarian, and other clinical and regulatory advisors, are conducting a thorough review of all data and records from patients taking both CaPre and placebo. This assessment is well underway, and the Company has also determined that a thorough investigation of the data must be completed and reviewed with the FDA, before the Company can report the findings from TRILOGY 1 and the implications for TRILOGY 2.
Consequently, the Company intends to request a meeting with the FDA to discuss the TRILOGY 1 data, and will seek their guidance about how to conduct the analysis of the TRILOGY 2 data prior to unblinding TRILOGY 2. The Company continues to remain blinded to the TRILOGY 2 data. Upon submission of the meeting request, which is expected to be sent to the FDA in calendar Q2, 2020, the FDA will have 75 days to review the findings and provide feedback and guidance.
Given the need to complete the audit and review of the TRILOGY 1 data, and obtain FDA feedback, the Company now anticipates the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020. Acasti will provide further guidance as to the timing of reporting TRILOGY 2 data based on progress of the audits and feedback from the FDA. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected as soon as possible after the unblinding of TRILOGY 2 results.
If the interpretation of the analyses produced as an outcome of the audits and post-hoc data review are supported by the FDA, and if TRILOGY 2 achieves statistical significance, Acasti believes it may still have a viable path forward to file an NDA for CaPre.
Jan D’Alvise, president and CEO of Acasti Pharma, stated, “Taking into account that the audit is still underway, that the data that we are evaluating is still preliminary, and that any findings will be subject to guidance from the FDA, we look forward to concluding the necessary work, which we hope will help us to better understand the unexpected TRILOGY 1 results. While we regret the additional delay in reporting TRILOGY 2 results, given our initial findings, we believe it is critical to conduct a thorough investigation and evaluation of the TRILOGY 1 results. Any learnings we can take from this investigation that may allow us to proactively adjust the SAP for TRILOGY 2, gives us a better chance of accurately reflecting the clinical value that we believe we still see in CaPre. Moreover, we have confirmed that there is established precedent for the FDA accepting post-hoc analyses of study results, assuming the analyses are transparent, well justified and well supported. We are moving as quickly as possible to gain a greater understanding of the TRILOGY 1 results, and will provide material updates as we learn more information. Furthermore, we project that our current cash position will now last through calendar 2020, giving us the necessary runway to complete our extended analysis of the TRILOGY program. We remain fully committed to our goal of gaining NDA approval for CaPre, and appreciate the tremendous support and patience of our shareholders.”
LAVAL, Quebec, Feb. 10, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, or HTG (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that a detailed examination of the Phase 3 TRILOGY 1 results for CaPre is underway, including specific clinical site audits and an audit of the central testing laboratory.
As previously reported, the Company noted a highly unusual placebo response in its topline triglyceride reduction primary endpoint, far greater than seen in any prior omega-3 triglyceride lowering trials, with 5 sites out of the total 54 enrolling sites disproportionately contributing to this placebo response. These sites accounted for about 36% of the 242 patients enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was conducted at 71 sites in Canada, Mexico and the United States that enrolled a total of 278 patients. The 5 sites also participated in TRILOGY 2, however these sites accounted for only 12% of the total patients, with the majority of these patients coming from only 3 sites.
Despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and identify protocol violations, the Company has subsequently identified some unexpected and inconsistent findings that it believes may have negatively contributed to the overall topline results. These findings are now being further explored via a comprehensive and rigorous review of data and patient medical records by an independent team of auditors. To support this effort, the Company, its independent Clinical Research Organization (CRO) that conducted the TRILOGY studies, its principal investigator Dr. Mozaffarian, and other clinical and regulatory advisors, are conducting a thorough review of all data and records from patients taking both CaPre and placebo. This assessment is well underway, and the Company has also determined that a thorough investigation of the data must be completed and reviewed with the FDA, before the Company can report the findings from TRILOGY 1 and the implications for TRILOGY 2.
Consequently, the Company intends to request a meeting with the FDA to discuss the TRILOGY 1 data, and will seek their guidance about how to conduct the analysis of the TRILOGY 2 data prior to unblinding TRILOGY 2. The Company continues to remain blinded to the TRILOGY 2 data. Upon submission of the meeting request, which is expected to be sent to the FDA in calendar Q2, 2020, the FDA will have 75 days to review the findings and provide feedback and guidance.
Given the need to complete the audit and review of the TRILOGY 1 data, and obtain FDA feedback, the Company now anticipates the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020. Acasti will provide further guidance as to the timing of reporting TRILOGY 2 data based on progress of the audits and feedback from the FDA. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected as soon as possible after the unblinding of TRILOGY 2 results.
If the interpretation of the analyses produced as an outcome of the audits and post-hoc data review are supported by the FDA, and if TRILOGY 2 achieves statistical significance, Acasti believes it may still have a viable path forward to file an NDA for CaPre.
Jan D’Alvise, president and CEO of Acasti Pharma, stated, “Taking into account that the audit is still underway, that the data that we are evaluating is still preliminary, and that any findings will be subject to guidance from the FDA, we look forward to concluding the necessary work, which we hope will help us to better understand the unexpected TRILOGY 1 results. While we regret the additional delay in reporting TRILOGY 2 results, given our initial findings, we believe it is critical to conduct a thorough investigation and evaluation of the TRILOGY 1 results. Any learnings we can take from this investigation that may allow us to proactively adjust the SAP for TRILOGY 2, gives us a better chance of accurately reflecting the clinical value that we believe we still see in CaPre. Moreover, we have confirmed that there is established precedent for the FDA accepting post-hoc analyses of study results, assuming the analyses are transparent, well justified and well supported. We are moving as quickly as possible to gain a greater understanding of the TRILOGY 1 results, and will provide material updates as we learn more information. Furthermore, we project that our current cash position will now last through calendar 2020, giving us the necessary runway to complete our extended analysis of the TRILOGY program. We remain fully committed to our goal of gaining NDA approval for CaPre, and appreciate the tremendous support and patience of our shareholders.”