Replies to post #370498 on Innovation Pharmaceuticals Inc (IPIX)

[CallMeCrazy]

COVID-19 Is Still a "declared" Public Health Emergency

The EUA pathway, established in 2004, allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases like COVID-19, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies...

This is the first time the EUA pathway has been used to address a national crisis of this scale...

Without the EUA pathway, the approval process for drugs to help COVID-19 patients could have taken a lot longer, if not years. And it’s still a pathway that manufacturers are evaluating to bring COVID-19 therapies to market today.

https://www.pharmexec.com/view/emergency-use-authorization-what-we-ve-learned-bringing-covid-19-therapies-to-market

Here's How the FDA determines the SAFETY & EFFICACY of an EUA candidate drug:

FDA recognizes that comprehensive effectiveness data are unlikely to be available for every EUA candidate product, and the information necessary to authorize emergency use of a product will also depend on the circumstances of the CBRN emergency, as well as available knowledge about the product's safety profile. FDA plans to assess the sufficiency of the effectiveness data and the risk-benefit profile of each candidate product on a case-by-case basis.
FDA recommends that requests for consideration for EUAs include any available relevant scientific evidence regarding the following:

• Product's mechanism(s) of action to diagnose, treat, or prevent the disease or
condition underlying the request;
• For drugs, preclinical testing data, such as in vitro evidence of the effect of the product in preventing or reducing the toxicity of the specified agent;
• Data on activity or effectiveness in animals that would contribute to understanding potential effects in humans, including but not limited to any animal efficacy studies available for products being developed under the Animal Rule;• Evidence from human experience relevant to assessing activity, effectiveness, and dosing (e.g., in published case reports, uncontrolled trials, controlled trials, and any relevant human use experience);
• For drugs, data to support the proposed dosage for the intended use (including pharmacokinetics and pharmacodynamics data, and for vaccines or antibody therapies, immunogenicity and/or achievement of protective levels of relevant parameters of immunity); and
• For IVDs, device performance data to support the intended use such as analytical sensitivity and analytical specificity, and data from testing fresh, contrived, banked or archived specimens.

Other Data Considerations

FDA recommends that a request for an EUA include the following types of data, as appropriate and to the extent feasible:

• Well-organized study reports that provide a complete assessment and analysis, including any statistical analyses, of available safety and effectiveness data and an interpretation of the findings. If final study reports are not yet available, any available interim study reports should be provided and clearly identified as such; and
• Source data for clinical studies, nonclinical laboratory studies, and any animal studies that contribute to assessing activity or effectiveness of the product in the treatment of the underlying disease or condition or a closely related disease or condition, such as case report tabulations for key studies; case report forms for all patients who died during the clinical studies and for all persons who did not complete the study due to an adverse event, regardless of causality; relevant reports in the published literature; and translations of source materials that are in a language other than English. FDA recommends that requests for EUAs include statements on whether the nonclinical laboratory studies were conducted in compliance with applicable Good Laboratory Practice for Nonclinical Laboratory Studies regulations (GLP) and whether the clinical studies were conducted in compliance with applicable Good Clinical Practice standards. FDA also recommends specifying the methods and quality systems used to ensure the quality and integrity of data from any animal studies submitted in support of an EUA request but not performed under GLP.
Data from any ongoing testing (e.g., longer term stability data) or other data or information that may change FDA's evaluation of the product's safety or effectiveness and that become available

https://www.fda.gov/media/97321/download

Why speed is important:

CTAP Dashboard

This dashboard provides a snapshot of development of potential COVID-19 therapeutics. Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, the following numbers may change frequently. FDA will update these numbers monthly. As of July 31, 2021, the snapshot is:

630+ Drug development programs in planning stages

460+ Trials reviewed by FDA

11 - COVID-19 treatments currently authorized for emergency use

1 - Treatment currently approved by FDA for use in COVID-19

https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#researchersdevelopers

The FDA, via the EUA process, is looking for safe and effective drugs/therapies that they can use NOWin the fight against COVID-19. These COVID-EUA candidates are evaluated by the FDA on a case-by-case basis.

Look at the criteria (above) the FDA uses and you won't see any mention of a Phase 3. When the FDA told the CEO of Rigel that their COVID P-2, with 59 trial participants, had too few participants, thereby not generating enough data, this suggested to me that Rigel probably didn't have a lot of previous data generated by the sources mentioned above. Remember, the FDA is looking at the totality of the data from clinical and nonclinical sources.

Keep in mind, the EUA process is an entirely different pathway than the drug approval process. Many here seem to confuse the two.

What IDIOT would say "NO, I don't won't to make these billion$ right now. I'd rather wait until after an unneeded phase 3.

Many here are knowledgeable about our science and the drug approval process, but seem woefully ignorant about BUSINESS.

There's room , IMO, for the first 3-5 COVID therapies to make billion$. Only roughly 16% of the world is vaccinated. No one company, including BPs, can service a market of this size.

Leo, let's focus. Forget about all our other indications and concentrate on B-COVID. This is our pivotal moment. Don't blow it. When the public health emergency is declared over, we're back to the slow, long, drawn-out drug APPROVAL PROCESS.