Ann: Ethics Approval to Treat COVID-19 Patients in Australia, page-97

the rapid set up of this trial in the US has meant that MSB has had no opportunity to consider launch of the product in another jurisdiction if the trial succeeds.

MSB is an Australian company and would have been in discussions with the TGA about the path to approval should the trial succeed.

I envisage the TGA has informed MSB that a potential path to accelerated approval in Australia is if they could somehow participate in the current trial run in the US... the good old piggy back / two birds with one stone trick.

The FDA would have been the ones MSB would
have had to convince to allow this to happen... the TGA is basically getting a free ride on MSB’s and the FDA’s quick response to the situation.

All these conversations and negotiations would have been started months ago and this is simply an outcome of those discussions.

To think that this is in any way a sign that we are struggling to recruit in the US is simply illogical.. especially when the clear benefit of this move is to expedite the approval in Australia and to eliminate the need for a separate trial to be run before Aussies can get access to the treatment.

Speed is of the essence and the FDA allowing the TGA to piggy back on their work is a huge positive and time saver for Australia... and the quickest path to approval for Australia .. the outcomes of these actions give us a very clear understanding of the motives behind them, but it won’t stop some from overlooking the glaringly obvious and instead let fear and doubt cloud their judgement.