James Gornick - Comments
PMD Forensic Analyst with Investment Insights
Retired P.M.D. Forensic Analyst with Investment Insights in economics who created theorems being bantered about for the Austerity v. Coase Oppression Investing Demographic Winter. As a seasoned Medical Biopharma and trained Forensic Analyst in Economics, I specialize in developing and applying ...more
Latest Comments
How Science Meets A.I.
19 days ago

KEEPING YOUR EYE ON THE TRUTH CAN BE A DIFFERENCE BETWEEN BEING IN $CAPR INSTEAD OF OUT OF A LONG POSITION.



President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration (FDA). Dr. Makary is known for his criticism of certain public health measures during the COVID-19 pandemic and has advocated for reducing bureaucratic obstacles within federal health agencies.


Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy (DMD). He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.


The FDA has recently approved several treatments for DMD, including:

 • Elevidys (delandistrogene moxeparvovec): A gene therapy approved in June 2023 for pediatric patients aged 4 through 5 years with a confirmed mutation in the DMD gene.

 • Duvyzat (givinostat): An oral medication approved in March 2024 for the treatment of DMD in patients six years and older, representing the first nonsteroidal drug approved for all genetic variants of DMD.


Dr. Makary’s potential leadership could influence the FDA’s approach to approving such treatments. While his intent to reduce bureaucratic delays may accelerate the availability of new therapies, his critical stance on certain FDA decisions suggests he may implement more stringent evaluation processes to ensure drug efficacy and safety.


In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.

In this article: CAPR
The Dream Team Disruptors - Einstein's In Biopharma 2020-2021
4 years ago

Keeping an eye out on Mesoblast MESO having a halt/pause in trading 12/16/2020 pre-opening. We see they are nearing a probable M&A event significantly increasing current share price well into $41-$78 dollars a share since they announced Phase III trial for CHF, but the actual positive results in saving lives from CV.

We are also upbeat with Arca Biopharma ABIO as can relate to current positive announcement from:

Dr. Wolfram Ruf, Scientific Director of the Center for Thrombosis and Hemostasis at the Johannes Gutenberg University Medical Center Mainz, Germany, and Professor at Scripps Research, La Jolla, CA, commented, “The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production. Because rNAPc2 is a potent tissue factor inhibitor, it has anticoagulant with anti-inflammatory and antiviral properties. With its properties in modulating the tissue factor pathway, rNAPc2 has the potential to be a uniquely beneficial therapy for patients hospitalized with COVID-19, and potentially other RNA virus associated diseases as well.”

We also suggest not to downplay Capricor CAPR with their VLP and mRNA SGV's true worldwide potentials being extremely robust with extensive spike-protein coverages without the actual side effects as being documented out of Pfizer's, Moderna's, and other FGV's currently having FDA EUA approval.

The other wakeup call is being sent with CytoDyn CYDY with their quite successful COVID-19 Long-Hauler trial. China's Plague sent the world is not going away anytime soon, even with the EUA FGV's being deployed.

We don't need to keep bringing major Lockdowns as being enacted by countries and states around the world. The answer in why no lockdowns needed come with the major Severe COVID-19 Infected patient treatments being provided by REGN, CYDY, ELY, ABIO, CAPR, AXDX, MESO, and SPPI.

In this article: AZN, JNJ, PFE, CYDY, ABIO, REGN, SPPI, MRNA, AXDX, CAPR, MESO, NVS
The Dream Team Disruptors - Einstein's In Biopharma 2020-2021
4 years ago

Thank you William for the kind thoughts.

In this article: AZN, JNJ, PFE, CYDY, ABIO, REGN, SPPI, MRNA, AXDX, CAPR, MESO, NVS
Blockbuster SAR-CoV2 Disrupters Pre-ICU / Admitted ICU Patient Treatments & COVID-19 T-Cell Vaccine Horizon
4 years ago

What will bring all back to work! Joe Biden is clueless... Keeping the eyes on the prize! POTUS Capricor, CAPR yesterday, beat on all numbers and has brought a VLP Vaccine into the long-term solutions FDA TRIALS CAP-1002. talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon PT $14 - $24 3-12 month outlook.

In this article: CAPR, ATHX
Staying Long Against High-Frequency Traders
4 years ago

What will bring all back to work! Joe Biden is clueless... Keeping the eyes on the prize! POTUS Capricor, CAPR yesterday, beat on all numbers and has brought a VLP Vaccine into the long-term solutions FDA TRIALS CAP-1002. talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon PT $14 - $24 3-12 month outlook.

In this article: GSK, SNY, INO
Staying Long Against High-Frequency Traders
4 years ago

Keeping the eyes on the prize:

Good connecting article for why the PT had hit the 52 weeks high $12.32 and maybe the reason for the August 6th or 8th earnings report in jacking the share price towards becoming a true M&A candidate or given the blessings of the FDA's approval for CAP-1002 BLA filing for uses.

READ:

talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon

READ:

endpts.com/microcap-capricor-soars-on-interim-phii-dmd-data-showing-functional-benefit-for-older-patients/

In this article: GSK, SNY, INO
Blockbuster SAR-CoV2 Disrupters Pre-ICU / Admitted ICU Patient Treatments & COVID-19 T-Cell Vaccine Horizon
4 years ago

Good connecting article for why the PT had hit the 52 weeks high $12.32 and maybe the reason for the August 6th or 8th earnings report in jacking the share price towards becoming a true M&A candidate or given the blessings of the FDA's approval for CAP-1002 BLA filing for uses.

READ:

endpts.com/microcap-capricor-soars-on-interim-phii-dmd-data-showing-functional-benefit-for-older-patients/

In this article: CAPR, ATHX
Blockbuster SAR-CoV2 Disrupters Pre-ICU / Admitted ICU Patient Treatments & COVID-19 T-Cell Vaccine Horizon
4 years ago

Very Important *****FYI for those seeking the best and earliest buy for both MESO with their BLA pending FDA approval on Remestence-L and CAPR CAP-1002 are just a few we are closely watching.

READ:

bioinformant.com/capricor-developing-treatment-dmd/ Inivio INO just got their BLA approval for their HPV suite of critical advancements in helping those stricken with Throat complications of HPV and that in critically advancing their VGX-3100 towards getting FDA final approvals.

Capricor CAPR has a few irons in the fire coming up when they present their upcoming second-quarter earnings and corporation pipeline status.

READ:

talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon

The first big iron for CAPR comes with a pending BLA for getting or meeting Orphan Drug Approval Status for their CAP-1002 for male boys and younger adult males with Duchenne muscular dystrophy (DMD) in 7 Major Markets.

This Iron is also quite remarkable with the incredible successes from the uses of MSCs and Exosome biotechnology advancements and the repurposing of their most current pipeline candidates awaiting approvals from the FDA for the accepted treatment protocols COVID-19 SARSCoV2; the eventual Orphan Drug Status for both Capricor CAPR CAP-1002 and Mesoblast LTD MESO for their Remestence-L.

Again, both MESO and CAPR for battling and achieving a true Disrupter Status in this war against China's born novel Coronavirus affecting our entire plant, since possibly October of 2019, when China kept this secret biological weapon hidden from the rest of the entire living masses around our world economies.

Keep up with the currently approved study for CAPR below as a link is provided. ClinicalTrials.gov identifier (NCT number): NCT04338347

READ:

https://clinicaltrials.gov/ct2w/NCT04338347

In this article: CAPR, ATHX
Staying Long Against High-Frequency Traders
4 years ago

Very Important *****FYI for those seeking the best and earliest buy for both MESO with their BLA pending FDA approval on Remestence-L and CAPR CAP-1002 are just a few we are closely watching. READ: bioinformant.com/capricor-developing-treatment-dmd/ Inivio INO just got their BLA approval for their HPV suite of critical advancements in helping those stricken with Throat complications of HPV and that in critically advancing their VGX-3100 towards getting FDA final approvals. Capricor CAPR has a few irons in the fire coming up when they present their upcoming second-quarter earnings and corporation pipeline status. READ: talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon The first big iron for CAPR comes with a pending BLA for getting or meeting Orphan Drug Approval Status for their CAP-1002 for male boys and younger adult males with Duchenne muscular dystrophy (DMD) in 7 Major Markets. This Iron is also quite remarkable with the incredible successes from the uses of MSCs and Exosome biotechnology advancements and the repurposing of their most current pipeline candidates awaiting approvals from the FDA for the accepted treatment protocols COVID-19 SARSCoV2; the eventual Orphan Drug Status for both Capricor CAPR CAP-1002 and Mesoblast LTD MESO for their Remestence-L. Again, both MESO and CAPR for battling and achieving a true Disrupter Status in this war against China's born novel Coronavirus affecting our entire plant, since possibly October of 2019, when China kept this secret biological weapon hidden from the rest of the entire living masses around our world economies. Keep up with the currently approved study for CAPR below as a link is provided. ClinicalTrials.gov identifier (NCT number): NCT04338347 READ: https://clinicaltrials.gov/ct2/shoVery Important *****FYI for those seeking the best and earliest buy for both MESO with their BLA pending FDA approval on Remestence-L and CAPR CAP-1002 are just a few we are closely watching. READ: bioinformant.com/capricor-developing-treatment-dmd/ Inivio INO just got their BLA approval for their HPV suite of critical advancements in helping those stricken with Throat complications of HPV and that in critically advancing their VGX-3100 towards getting FDA final approvals. Capricor CAPR has a few irons in the fire coming up when they present their upcoming second-quarter earnings and corporation pipeline status. READ: talkmarkets.com/.../blockbuster-sar-cov2-disrupters-pre-icu--admitted-icu-patient-treatments--covid-19-t-cell-vaccine-horizon The first big iron for CAPR comes with a pending BLA for getting or meeting Orphan Drug Approval Status for their CAP-1002 for male boys and younger adult males with Duchenne muscular dystrophy (DMD) in 7 Major Markets. This Iron is also quite remarkable with the incredible successes from the uses of MSCs and Exosome biotechnology advancements and the repurposing of their most current pipeline candidates awaiting approvals from the FDA for the accepted treatment protocols COVID-19 SARSCoV2; the eventual Orphan Drug Status for both Capricor CAPR CAP-1002 and Mesoblast LTD MESO for their Remestence-L. Again, both MESO and CAPR for battling and achieving a true Disrupter Status in this war against China's born novel Coronavirus affecting our entire plant, since possibly October of 2019, when China kept this secret biological weapon hidden from the rest of the entire living masses around our world economies. Keep up with the currently approved study for CAPR below as a link is provided. ClinicalTrials.gov identifier (NCT number): NCT04338347 READ: https://clinicaltrials.gov/ct2w/NCT04338347

In this article: GSK, SNY, INO
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