Quanta Inc (fka QNTA)

[falon]

Situation Awareness


Covid 19 Pandemic

Solution

Vaccines

The current vaccines work however better ones are needed and are being developed.

Other treatments

Here is were a major problem exist.


While some available treatments have been helpful there is nothing on the market that after contracting Covid, getting very ill and being hospitalized will shut the virus down.

We need treatments that will shut Covid down swiftly and effectively.

QNTA may have the solution and other companies will provide other solutions.

This is an "ALL HANDS ON DECK" situation.

There are faster ways to get drugs approved:

FDA Drug-Approval Process


A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

First, the company must conduct laboratory tests and try the drug on animals and then people to make sure it works and is safe.

Faster Approvals


In 1992, the U.S. passed the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from companies to expedite the drug-approval process.

The act establishes two time frames for gaining approval: Standard Review and Priority Review.

The goal for standard review is to get a drug through the approval process in 10 months. This type of review is applied to a drug that offers little to no improvement over other therapies already on the market.

Priority review is a designation reserved for drugs that offer major advances in treatments or that provide treatment where none existed. The FDA aims to get a drug through the entire process in six months.

Further, the FDA has an accelerated approval pathway for some drugs used for serious and life-threatening illnesses that do not have adequate treatment. A limitation of the accelerated approval pathway is that it allows an NDA to be approved before means are available to fully measure the drug’s effectiveness — a step that would usually be required.

“Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness,” according to the FDA. “These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit.”

Other avenues for faster review include breakthrough therapy or fast track designations. These avenues are used for drugs for serious conditions that demonstrate substantial improvement for treating the disease or fill an unmet medical need, respectively.

https://www.drugwatch.com/fda/approval-process/

Final Thoughts:


Desperate Times Call for Desperate Measures


Interesting fact about Desperate Times Call for Desperate Measures

The expression ‘desperate times call for desperate measures’ is believed to have originated with a saying coined by the ancient Greek physician, Hippocrates. In his work Amorphisms, he wrote: “For extreme diseases, extreme methods of cure, as to restriction, are most suitable.”