This week should see an announcement about the dosing of the second patient in the first cohort of Benitec's ($BNIKF, $BTEBY) TT-034 clinical trial for the treatment of Hepatitis C (HCV).
I am aware that the delays in the dosing of patients have been the cause of some criticism of the company's management. As a long term investor in the company I can appreciate the frustration being vented by some shareholders as we draw nearer to a value inflection point. However, despite the company's CEO and Managing Director, Dr. French, explaining the delays, some critics still appear to want to push the barrow that management, or mismanagement, is the real cause of the problems and reason why the share price is under pressure.
It is not my place to try to extend beyond Dr. French's explanation the reasons for the delays; one has to either believe him or not. However, I can point to some facts which seem to be overlooked by some of the critics.
The first point that I would make is that the company engaged SynteractHCR as a Clinical Research Organisation (CRO) to assist in the submission to the Recombinant DNA Advisory Committee (RAC). Based on the information provided, the RAC unanimously approved a recommendation supporting the start of a clinical trial for TT-034.
The time from RAC approval to FDA IND approval was about the same time as that required when Calimmune went through the same process of starting its Cal-1 trial for the treatment of HIV.
Based on the excellent outcome of the RAC process, the company awarded SynteractHCR a further contract to manage the TT-034 phase 1 (Pl/Plla) trial. To the best of my knowledge, this contract is still in place. What this means is that, unless critics have evidence that SynteractHCR is not managing the trial, then they have no basis upon which to be critical of management with regard to the dosing delays.
To assert that no CRO has been engaged by Benitec is simply wrong.
The employment of a CRO means that company management is kept at arms length from the daily management of the project. This point was made by Dr. French but it appears some commentators are choosing to ignore this fact. Dosing is entirely the function of the CRO and the clinicians at the trial site(s).
I hope that the second patient is dosed this week and that the trial runs smoothly from now on. However, regardless of what happens, I will make my assessments based on the facts of the matter rather than unsubstantiated rumor and innuendo and I urge other shareholders to do the same.