Replies to post #149611 on Innovation Pharmaceuticals Inc (IPIX)

[winnail]

Thanks,Sox-I mean MR.SOX- you are doing a really good job stating the FACTS-good work

[TheHound]

Thanks Sox! And as BK has pointed out on more than one occasion,.....

What is in question are the elements of QIDP fast-rack that will be applied. At least one and possibly up to all of the following are possible and will result from the FDA Phase 2 meeting.

Accelerated review only. (Reduces the review time between trials from > 10 months to ~ 6 months)
Rolling review
Surrogate endpoints
FDA intensive guidance and organizational commitment
60 day FDA responses

The trifecta: rolling review with surrogate endpoints, intensive guidance and organizational commitment, 60 day BLA and NDA guaranteed response time.

Also, some of the elements depend on a sponsors ability to guarantee rapid marketing and product quality after approval. In CTIX's case that will require a partner or license.

http://investorshub.advfn.com/boards/replies.aspx?msg=115224134

[Amatuer17]

Thanks

So basic question is - why Leo did not request FTD yet? What he is waiting for?