I have a few minutes this morning with no patients so I’ll offer my estimate:
Their update stated the next phase begins in March after “development and delivery” of custom antibodies. I don’t know who is developing those or which they are, but there are a few companies who do that work and it involves significant time and costs. The update says good results were obtained for a yeast and a couple of bacteria so I think they didn’t find commercial antibodies available for the other microorganisms they want to test or they weren’t satisfied with the results for those they had. Since this is a pretest for their N-Assay process one has to believe there has to be compatibility of results in both processes, meaning any positive results for the pretest have to be followed by the same patient samples being used in the N-Assay to determine severity and antibiotic application.
After that development step is complete for the target bacteria is when the patient studies occur. Any researcher will want to know the test combination has performed reliably and consistently in development with proxy samples covering a range of microorganisms that will be tested for in the patient sampling during the tests. The studies will have to meet FDA standards and then be published upon completion, with the potential for publication of the results for different phases.
Duty calls, but that’s as thorough as possible as viewed from public data.