BTA biota holdings limited

So to spell it out:The anticipated PCR positivity rates were...

  1. 8,256 Posts.
    So to spell it out:

    The anticipated PCR positivity rates were 70%+ i.e. they expected 70%+ of people going to the doctor thinking they had the flu would actually have the flu, when in actual fact, it was not so - many instead might have had bad colds/HRV or other viruses.

    The positivity rate was more like 40% (only around 40% of people with flu like symptoms presenting to the clinical trial locations actually had the flu). Apparently similar issues found with that other trial taking place (Phase 3 and they enrolled even more candidates).

    So what you are saying is, RP will hopefully be using this evidence to go back to BARDA (as a partner) and the FDA to plead that the Flu positivity rates were lower (completely out of Biota's control) than expected, and therefore, the trial numbers should be lowered (to around 229 out of approx 572 candidates enrolled, rather than 444 out of an anticipated enrollment of 636 candidates). I guess with this being a Phase II trial, the chances for success in his plea might be better than that other company doing their Phase III - also the fact that we have Japanese evidence (even though the FDA would not accept this data).

    As an aside, imagine if there was a parallel clinical trial for VAP for non-respiratory compromised candidates taking place???!!!!
 
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