BioSig Tech. (BSGM) & Electrophysiology Sector - - vaccine hype continues - BioSig Tech. (BSGM) & Electrophysiology Sector - InvestorVillage
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Msg  1197 of 1296  at  6/30/2020 12:27:35 PM  by

2abetteryear

The following message was updated on 6/30/2020 12:28:02 PM.

 In response to msg 1196 by  Rob Cos
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Re: - vaccine hype continues

Seems that if a company is pursuing a vaccine, they get a 10x-20x market cap bump over a lowly TREATMENT developer like BSGM/ViralClear.

Not so fast, and not so easy. See article below in today's WSJ...


FDA Outlines Its Conditions for Approving a Covid-19 Vaccine
Treatment would need to be at least 50% more effective than a placebo in preventing the disease

By Thomas M. Burton - WSJ

Updated June 30, 2020 11:20 am ET

WASHINGTON—The Food and Drug Administration released guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.

The FDA said that no vaccine would be approved unless a vaccine company had “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, according to the guidance.

The FDA also said a vaccine wouldn’t be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.

The FDA said it would also require a vaccine maker to conduct further monitoring of safety after any approval and recommended that people getting the vaccine be followed for a year after treatment. The summary document said that such “post-market studies” may be necessary to “further assess known or potential serious risks.”

“We have not lost sight of the need to protect our regulatory independence” even during the Covid pandemic,” Dr. Hahn said. In response to senators’ questioning, Dr. Hahn said he is also optimistic that therapeutics like convalescent plasma and monoclonal antibodies will play a significant role this fall in helping people infected by Covid-19.

Developing a vaccine is a priority for the Trump administration, which has dubbed the initiative Operation Warp Speed. The FDA has vowed to use all its available authority to expedite a safe and effective Covid-19 vaccine, fueling hopes that a preventive treatment can be developed quickly.

The Wall Street Journal reported earlier that the guidance would be released Tuesday, quoting a summary of the guidance in which the FDA stated that it “will not reduce its standards or cut corners in its review to approve a vaccine.”

The FDA has sometimes been faulted for moving too quickly in the campaign to prevent and treat the virus.

At least 160 antibody tests for Covid-19 entered the U.S. market without previous FDA scrutiny in March, as the agency rushed to get them to the public quickly. Under fire, the FDA mandated stricter review.

The agency also granted emergency-use authorization for two malaria drugs, chloroquine and hydroxychloroquine, for Covid-19 treatment, which it later revoked after determining both were ineffective.

Guidances are a method the FDA uses to state its policy to an industry, in this case vaccine makers. A virus vaccine could be granted approval two ways—either as a full approval or as emergency authorization.

An emergency authorization could happen more quickly than a full FDA approval, but would still require the vaccine maker to show through a clinical study that the vaccine produced lower levels of disease.

Government and industry officials have concluded that the standards the FDA is espousing for full approval will need at least 30,000 people in a clinical trial. But since the coronavirus pandemic has flared up again in the U.S.—including in Arizona, Florida and Texas—it may well be relatively easy for companies and doctors to sign up patients eager to see if they can participate in a vaccine study that might protect them.

Write to Thomas M. Burton at tom.burton@wsj.com


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