Maybe Mr. Market is starting not to listen.
In relation to the IND submission, PR stated "Do it right, get it right the first time" to explain away the length of time to drop the IND - and look where we are - over a 3 month delay.
Can't wait for the 3-4 peer reviewed publications to drop - but we've been waiting for 2 years.
TGA provisional approval.....In the interview with Capital 51, PR said the TGA informed them that there are existing therapies that work as well for pain or function and that to prove a "serious therapeutic advance" they would have to show DMOA effect - so risk elevated.
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- Ann: IND QUESTIONS RECEIVED FROM US FDA
Ann: IND QUESTIONS RECEIVED FROM US FDA, page-290
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