Ann: BIT225 Effectiveness Against COVID-19 in Animals, page-92

Also any update on the pre-IND submission will set the rockets up as well, this should of been done since November last year.

Just keep the market updated on your progress and gain the trust back MnM........

Q. How can I maximize my chances of starting a trial for my investigational therapy for COVID-19 as quickly as possible?

• By presenting a strong scientific rationale and supporting data showing that the therapy is appropriately safe to enter clinical trials and has the potential to be effective in patients.
• Start by taking full advantage of our pre-IND program. We have found that a complete pre-IND submission is the key to expediting comprehensive pre-IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation. Guidance regarding pre-IND meeting request content for COVID-19 drugs or biological products is at: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 related Drugs and Biological Products.
• General information on how to efficiently engage with FDA and expedite clinical trial initiation is at: Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency.
• Guidance concerning the development of drugs and biologics to treat and prevent COVID-19, including issues such as population, trial design, efficacy endpoints, safety considerations and statistical considerations, is at: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. Note that preventative vaccines and COVID-19 convalescent plasma are not within the scope of this guidance. Recommendations concerning these products are addressed in separate guidance on Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry and Investigational COVID-19 Convalescent Plasma.
• Additional, detailed information is available at our CTAP website, at: Coronavirus Treatment Acceleration Program (CTAP).