JB, both you and Hoyland present a strong interpretation of management’s dilemma the essence of which I won’t dispute. That said I don’t feel that entirely excuses management from updating investors as relevant data become available. Given they have biopsied 3 patients then data are available.
I have set issues of safety aside as in my view it’s not in question – the preclinical work on mice and monkeys convinced me of that and really we are going through the proof of safety for the FDA benefit.
So I readily accept that it will safe up to and actually beyond the max dosage proposed in this trial.
What I want as reassurance from the efficacy perspective is (at the very least) a statement that says results are consistent with expectations – which are stated as:
Within that framework all I want to know is
- Continuously produces replenishing pool of shRNAs for over 180 days
- shRNA target three separate, well conserved regions of HCV RNA genome
- Capability for near complete hepatocyte coverage (transduction)
1) Is there evidence of expression of the respective RNAi elements in the relevant liver target areas? Is that in line with expectations?
2) Depending on the target area and particular RNAi element is there any evidence of sustained transduction of hepatocytes? Is that consistent with expectations?
(The elements to which I refer are shRNA- 6, 19 and 22 which target 3 separate regions of the HCV genes/DNA in cells)
Frankly, I don’t really think that is too much to ask and could be covered in a simple paragraph. If I had such an update I would be tempted to buy some more shares!
Regarding length of the trial I can’t see any reason no matter how sensational the interim results might be why FDA would agree to shorten the trial. We certainly don’t meet criteria for orphan drug status and we won’t have Proof of Concept until conclusion of Phase 3.
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