It remains to let the results of the murine MASH results play out and let Cytodyn comment on next steps…we should know soon! Where I might deviate with your assumptions is in recognition of the fact that Cytodyn I believe is paying for this trial, ergo they own the results and can do whatever they want with them…they are not beholden to Madrigal necessarily unless there were discussions with Madrigal and certain agreements made (I have no detail on that). In theory they would not need Madrigals permission to use their drug (simply a comparison with standard of care much like the CRC study) but I don’t doubt there may have been discussions with Madrigal about potential next steps predicated on results. Unless Madrigal provided some kind of funding partnership in the pre-clinical, I don’t think Cytodyn would have put themselves in a position to be handcuffed, especially with a “cheap” study at around $250,000. They included a Leronlimab only study arm for a reason. If the Leronlimab only arm is far superior to Madrigals drug and the combo is not additive in clinical impact Cytodyn should be free to announce the results and it will be open season on BP to seize the day and do an end run around Madrigal. By the same token if the results are additive both Madrigal and Cytodyn would have incentive to get the results out there right away as it has the potential to add shareholder value on both sides of the aisle.

Much depends on how a study is funded. Any FDA approved drug can be purchased through wholesalers like McKesson and should not need the manufacturer’s permission to use in a study. The drug company that funded the study in effect owns the data and can do with it what is in their best interest.