We've heard they've already got the tox material made and ready to ship to BASI, but are waiting on developing the appropriate testing methods to detect the cides in animals before they proceed:
"We are also continuing to develop additional tests that are needed for analyses of samples from animals that will be generated during the safety/toxicology studies, and later in the human clinical trials. Such tests are needed for estimating a drug’s distribution pattern in the body as well as the time profile of the distribution. Such tests are also needed to decipher the metabolic fate of the drug. Since a nanoviricide drug is not a simple small chemical or an antibody, development of these tests is relatively complex, and is taking a significant amount of time."
Can't very well do tox without these analytic methods in place for PK studies - thus the hold-up.
Re: "If they can't make the 'cide for the TOX, how can they make the Ebolacide for its testing? Is Ebolacide simpler to manufacture?"
They had trouble scaling up at the old facility. The new facility should enable 200g->1-3kg batches, a 5-15 fold improvement in batch yield. Plus they can probably run more batches in parallel in the new plant. They are still working on the characterization and process control methods of nanomicelle production at larger batch sizes (the "scale-up").
So, everything will be easier to make in larger quantities in the new plant, coming online soon (2-6 months?, certified cGMP in ~12 months?) They are estimating being able to produce several hundred thousand doses of FluCide per year at the new plant.
Timing is slower than hoped... thus the recent beating
