BGT 0.00% 5.3¢ bio-gene technology ltd

Ann: Successful Stage 2 Completion of Program with BASF and GRDC, page-16

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  1. 174 Posts.
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    I'm definitely no expert on the subject but I did a bit of digging into this so will share. Always DYOR - I would also suggest reaching out to management.

    https://apvma.gov.au/ - lots of good base info to look at on this website.

    Right now BGT is taking a de-risking approach to studies on both Flavocide and Qcide. The company updated the market recently with regards to this strategy in action (eg. see Ann's = 'Preliminary results of avian Eco-toxicity study on Flavocide' - 14/07/2020, 'Preliminary aquatic eco-toxicity studies' - 04/06/2020). These studies assist in answering questions relating to the relative safety for human and animal exposure, as well as the general environment - it also provides a baseline to move discussions forward from. So whilst the tests are 'preliminary' they tick a major box that these companies want to see in order for them to take the next step in formalizing agreements etc. It also ensures that when we do arrive at the time of submission to APVMA that we have all of our ducks in a row. BGT is de-risking and moving along nicely with positive results reported thus far.

    As far as the expected timing for the APVMA Cert, if I had to make a semi-reserved guess I would say second half of 2021 or early 2022... but pretty hard to put a timeline on that one. Sometimes these things can get fast tracked, especially when you have multinational companies with big cash reserves/experience to assist in navigating the process.

    When I reached out to management with a similar question, they informed me that there is no set path to registration, as it depends on the information they collect along the way. The rational being that by taking this approach BGT can theoretically eliminate any unnecessary testing that results in lost time and funds.

    As far as your question re approval for sales outside Australia - it's an interesting question, but one that I could not find an exact answer to - it seems that there are variable scenarios based on each countries laws. I would love to get more info on this as well if anyone else understands the big picture. Regardless, if we strike a formal deal with one of these multinational companies, I think you can rest assured that they will know the ins and outs of these processes better than anyone.

    Hope that helps a little bit!

    Cheers
    Last edited by Jailwarden: 22/09/20
 
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