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A researcher into gene silencing as a technology for improving the lives of those suffering from incurable diseases. Benitec Biopharma is my primary investment in this technology as ddRNAi offers one-time treatments for a broad range of these diseases.
  • TT-034 Clinical Trial Management 7 comments
    Aug 17, 2014 2:07 AM | about stocks: BNIKF, BTEBY

    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.

    Stocks: BNIKF, BTEBY
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Comments (7)
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  • omcdac
    , contributor
    Comments (230) | Send Message
    This is very imp update Panno.
    17 Aug 2014, 04:40 AM Reply Like
  • brama66
    , contributor
    Comments (176) | Send Message
    Thanks again, Panno. Yes, this has been explained even by others familiar with clinical trial processes, and yet many continue to be critical of management. I personally believe it is an attempt to legitimize illegitimate anger for a share price that is not at their assumed level. I think part of that is because many of us, myself included, believe in the tech so much, that we are all still amazed that the share price is still so low. Regardless, shareholders need to be aware of the facts, and not allow unrestrained, and rather illogical anger to be vented misdirected. Thanks for the insight Panno.
    17 Aug 2014, 07:41 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (245) | Send Message
    Author’s reply » I think that you are spot on brama66. I wonder if those doing the criticizing will ever admit that their comments about dosing are baseless? One thing is for sure, they will never apologize to Dr. French for leveling baseless allegations against him.
    17 Aug 2014, 08:11 PM Reply Like
  • brama66
    , contributor
    Comments (176) | Send Message
    I doubt they will. But one thing is sure, many of them will quietly back down after be shown with facts just how baseless their complaints are. I think many thought that benitec would be "quick money", and had unrealistic views regarding how share price is valuated.
    17 Aug 2014, 09:06 PM Reply Like
  • danno123
    , contributor
    Comments (6) | Send Message
    Love ya work Panno - keep us "informed" .. cheers Danno123
    18 Aug 2014, 01:45 AM Reply Like
  • pga2003
    , contributor
    Comments (70) | Send Message
    Another fact based commentary by the very capable Panno. Good job and keep up the work.
    17 Aug 2014, 08:40 PM Reply Like
  • wwtmm
    , contributor
    Comments (2) | Send Message
    Thanks for your work Panno.
    18 Aug 2014, 08:55 AM Reply Like
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