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agm notes

  1. TDA
    11,411 Posts.
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    Just some notes I have taken at the AGM, my interpretation only. Well it was a good meeting and rather bullish for me on a lot of fronts, management genuinely share the frustrations of holders with the FDA delays because they are cocked and loaded to do so much more as soon as it?s here.

    Here are a few things I found interesting and I suggest everyone go over the presentations because there is a lot of new info in there and is rather comprehensive.

    My notes (I?ll try to keep most of what?s in the presentations out):

    VAST Technology ? Due to the size and scope of staffing needed to progress this in-house the company has decided to try and realize this technology through collaboration instead, they have been very busy this year signing several deals with major pharma companies and smaller ones as well. This in turn may return a lot of capital to the company so they can progress with and concentrate more on the commercial opportunities we have with Fonda (including Oral) and the HyACT platform (including the phase 3 HA-Irinotecan trial for colorectal cancer and phase 2 HA-Irinotecan trial for small cell lung cancer). Watch this space, they wont be vocal about it but there could potentially be one big or many smaller deals done here.

    HA-Irinotecan ? The trial will now cost $25m instead of the stated $20m due to the change in Protocol and in turn the need for more patients, going from 330 to 390. They wish to make sure they capture all data needed hence the increase in patients. This was referred to as ?our phase 3 asset? many times and Pete Smith believes that the market will add significant value to it (shareprice) once the FDA approve Fonda, they seem more excited about HA-Irinotecan than they do Fonda, it was mentioned again that this has the potential to earn ACL 100?s of $millions and we are clinically further advanced than the competitors (eg PEG ? years ahead). They may start a partnering campaign early next year once the trials have started, P.S said again though that they don?t need it and if they were to partner it would have to be a deal they couldn?t refuse, he is really bullish on this one.

    Fondaparinux ? Well we all know what we are waiting for and jeez it sounds very close. Pete said that FDA actually had 2 inspections to do and that the first one was done and the second was to be within days. The clincher, he mentioned that they expect it to be a matter of only weeks after this, but wait there?s more:

    They were told by the FDA that there are NO further questions to answer and that the inspection is the only thing left!!

    Pete expects a rapid take up of Generic Fonda and mentioned the Generic Enoxaparin (same space) stealing 45% of sales in the first 9 weeks, he said it is a simple economic switch by patients and hospitals to the cheaper alternative.

    For Tewk, we can submit for European approval by the end of this year, ready for sales in 2012, Reddy?s will be doing this.

    I will leave it at this as I see some want it, yes I bought a few more too:)

    I?m sure I?ve missed a few things and will add them later if I remember anything.



 
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