| | | Scale-up is intrinsically tricky to even talk about:
- Scale-up is done for each stage and each step of production (micelle formation stage, ligand formation stage, micelle and ligand attachment stage), and each of these stages has multiple steps. Some stages and steps scale up better than others. (I think Seymour once told me there were 14 steps to scale up for FluCide...but my memory may be weak on that matter.)
- Initially, the company thought scale-up to 2.5 kg batches was quite doable. But scale-up has proven to become more difficult than expected, and there may be practical limits above about 1 kg for even the easiest steps. We may not make it past that batch size in the next few years.
- This reality has caused the company to go back and revise the ligands to become more effective...i.e., to require less drug material.
- The micelle backbone has also changed over time to support better oral and topical drug delivery.
- Each time the backbone or the ligand changes, two of the three stages of the scale-up have to be re-done. (Hopefully, we're getting better and faster at redoing scale-up.)
As a result, the company has a difficult time explaining what they can and cannot do. I though what was written in the latest 10-Q was the best explanation yet from the company showing the complexity of the issue of production. But it's not easy to follow.
It's still unclear how long the company thinks this process is going to take. I wish the company was more transparent with schedules and time lines, but they have burned themselves numerous times with their overly optimistic projections. I'm not sure which is worse: 1) a schedule they find they cannot meet, or 2) an opaque schedule.
I wish we at least had a clear picture of the milestones, but that is rather opaque as well. And things move slowly...frustratingly slowly.
Perhaps I'll go through the 10-Q and do my best to pull out the milestones in both clinical development and production that Diwan has articulated. There is more in this 10-Q than I have seen in previous filings. It's less opaque...but still pretty murky.
I think we will be able to produce at commercial introduction levels, but I have no idea at what unit cost we can do it. Lots to think about with this company... |
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