Replies to post #235816 on Innovation Pharmaceuticals Inc (IPIX)

[Amatuer17]

Actually the suggested path says that have a meeting with FDA before applying for BTD

“FDA had previously responded to this asymmetric resource requirement by educating Sponsors on BTD requirements (see FDA’s presentation from 2015) and requesting that Sponsors discuss the viability of a breakthrough therapy designation request prior to actual submission of a request.”

FDA BTD database shows all BTD applied and decisions (someone on other board had provided the link) and it showed that most decisions were issued in 60 days.

So if Leo did not have meeting with FDA and not applied by now - it is unlikely that he will get decision by Sept 30th

Old Leo would have informed us in a PR but with Dr B, he will not issue PR but he may have to add it to 10-q

[PlentyParanoid]

So typical! People are missing the most important question: What kind of bike?

And a minor thing: it is hard to argue that not receiving BTD is material event when a good portion of biopharma industry is in no hurry to make public FDA's complete response letters. Let's start getting those to be recognized universally as material events.

[To infinity and beyond!]

Despite the fact that 2 guys in my dept have motorcycles they sometimes ride: you have to be completely nuts to ride a motorcycle, from an ED public health perspective