Support: 888-992-3836
Copyright © 2023 InvestorsHub Inc.
Replies to post #2060 on Akers Biosciences Inc. (AKER)
HokieHead
04/07/20 9:39 PM
#2061 RE: CWO #2060
We intend to engage with the regulatory authorities, the FDA in the U.S. and the office of the drug controller in India appropriately and scope out the regulatory path forward. Next, we plan to initiate manufacturing development in parallel, where we would carry out the scaling up and the manufacturing development alongside with the formulation study. We wish to initiate animal trials as soon as we have material with us in the coming weeks. There could be a possibility that the regulatory authorities may allow us to proceed directly to human clinical trials, similar to Moderna, depending on the discussions and the possible guidance on the matter.At the end of this phase, we plan to release data associated with the animal trial.