CZD 3.13% 9.3¢ calzada limited

bioshares report, page-27

  1. 5,263 Posts.
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    I think you are looking at this from a skewed perspective that is making a mere mouse look more like an elephant.

    I do not believe that the Company ever anticipated funding a complete suite of trials to support a US PMA submittal entirely on its own.

    I think it more likely that it was anticipated that the planned Australian human trials - including burns trials - short of the full requirement for PMA in the US would attract a partner who would fund the full suite of trials necessary to satisfy the FDA.

    Then along came the prospect of a BARDA grant. Great.

    Meanwhile, we have completed human trials for the NPT dressing and for the BTM for surgical reconstruction (other than deep burns), and have already entered the regulatory approval process for the NPT dressing in the US, with commercial discussions with potential distribution partners in progress. A commercial deal could come literally at any time.

    BTM is soon to follow the same track, and a possible BARDA grant coming 1Q2014.

    Your posited potential need for a further cap raise is speculative, premature, and overly pessimistic.

    On the other hand your potential timetable for BTM to be cleared to market in the US for deep burns is anything but pessimistic. Burns trials will tend to drag on depending on the availability of burn victims for treatment.

    As to timing of a buy, sure, you could wait. But a rerating could come without warning, especially if there is a deal on the VAC dressing. That event would be a definite "before and after" situation, keeping in mind the size of the market we're talking about.
 
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