Let's look forward to Phenomenal success outcome of the ongoing concurrent Four HIV Trials.
All look good!MM et al.'s words ( all public announcements) about partners for CoVID:
(i)
Demonstration of reduced virus levels in the lungs of these mice will validate Biotron’s approach and represent a key milestone for the
program (
Came True)
(ii) (Hopefully, many expectations will come true)
Biotron is now in discussions with its
USA advisors and consultants to expedite progression of
BIT225 into human trials for treatment of SARS-CoV-2 infection. The Company has sufficient
drug product on hand after recently completing the manufacture of several kilograms of
additional clinical grade (cGMP) drug.
The Chair of Biotron’s Scientific Advisory Board, Professor Rob Murphy, Professor of
Medicine and Biomedical Engineering, John P. Phair Professor of Infectious Diseases at
Northwestern University, Chicago, said, “
These very encouraging results in a SARS-CoV-2animal model demonstrate a robust antiviral response that justifies further study in humans.
BIT225 is a novel antiviral drug that has been safely used in over 200 patients with other RNA
viral diseases including HIV and hepatitis C.
This is drug that should be studied as a COVID19 treatment in the very near future.”
Biotron’s Managing Director, Michelle Miller, said “These results suggest that BIT225 may have benefit over other known antiviral agents. We will actively pursue all avenues to progress this Biotron drug into human trials as quickly as possible.”
(iii) (Hopefully, many expectations will come true)
The Company is currently mapping out a clinical and regulatory pathway for treatment of COVID-19
with BIT225 in consultation with its USA-based advisors and consultants. Designing a suitable trial
in the current fluid environment of the pandemic requires careful consideration of the clinical,
regulatory and epidemiologic features of the SARS-CoV-2 virus. This process involves coordination
between the Company, international medical experts in the treatment of COVID-19 and clinical trial
design, regulatory authorities and funding agencies.
The U.S.A. Food and Drug Administration (‘FDA’) has created a special emergency program for
possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (‘CTAP’). The
program uses every available method to move new treatments to patients as quickly as possible.
Biotron is preparing a detailed briefing package to submit to the FDA during the first quarter of 2022.
Guidance from the FDA will inform the final design of a suitable international trial and will be a key
component of outreach to potential partners. [This should/will come True like the one (i) above ]
Biotron Limited (ASX: BIT) is pleased to announce that it has received an R&D Tax Incentive refund
of $1,411,944 R&D Tax Incentive refund for the 2019/20 financial year. Hopefully, in 20/21 FY, Biotron should receive more R&D Tax Incentive refund.
All Biotron's works look good, good patient guys (holders/non-holders!
