When investing in biotech it is useful for example to understand what co-primary endpoints means and recognise an issue when a company entirely fails to report the baseline to EOS mean score of one of them.
Secondly when a much later PR then declares success based on one co-primary and one secondary endpoint, it should be clearly recognised that the trial did not meet its per protocol endpoints.
There is little doubt that ADCS-ADL was a fail despite the company oddly claiming all endpoints were met with statistical significance in an 8-K and subsequent SEC filings.
To patch this up the company chose to report Odds Ratios incl. for ADL, but have so far failed to report how many patients met the thresholds reported, redefining those result outcome measures is both unusual and pretty useless without the necessary context.
In later PR the company started focusing on Accelerated Approval and stated that a confirmatory trial would be conducted in parallel with pursuing AA discussions with the FDA.
Now 16 months after trial completion it is still not clear if there has been discussions with FDA and what might be the outcome of those.
This series of events won’t pass without serious biotech investors raising at least one eyebrow.
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