yes, this has been a very long time coming. We expected to be at this point the same time last year. Now, finally the things beyond their control that commonly result in delays have been surpassed and now its all down to the analysis.
If there are clear signs of significant viral response in the target cells then there is a very real chance of a stock rerating here. Despite the excellent recent results from the HCV trial followup the SP is depressed largely over concerns over the competativeness and speed of change in the HCV space. While BIT is far from out of the game there, seeing good HIV results from the same drug which already has proved HCV benefits should change the risk profile of Biotron dramatically.
A decent entry into the HIV space might give BIT225 renewed chances of a partnership for a HCV combo trial if for no other reason than new combos formulated for the co-infected which Biotron have stated is one of their key target areas. Of course a HIV specific combo trial would be even more meaningful from a stock perspective.
This is a very exciting time. A possible game changer as many have said but lets not get ahead of ourselves. What we need from this trial is to know that its safe and that it shows clear signs of clearing the virus from the target cells. Dosage and duration optimization can then be expected in future trials which would likely be combo trials in which the truely exciting headline numbers are usually achieved. Lets be careful not to have anybody set us up for disappointment by expecting huge headline numbers from this mono trial.
Biotron's track record for success in trials of BIT225 is very good. Unfortunately they just seem to take forever. The fact that they had the confidence to launch a new co-infected trial before even completing this one shows that they are pretty confident of what the broad outcomes will be here. The market however needs confirmation and the current data analysis could finally be the catalyst for a partnered combo trial design to start while the new longer dosing period study is underway.
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