Replies to post #249534 on Innovation Pharmaceuticals Inc (IPIX)

[Jhawker]

B-OM already has fast track designation correct?

[Amatuer17]

“BTD is not at all critical to advancing B-OM to Phase 3 nor is it in any way critical to a partnership or license...”

I agree with 1st part - P3 can proceed without BTD - most of the products go into P3 w/o BTD.

The board has talked about BTD as a validation by FDA about product which will fetch higher deal value.

While you can twist the words, the
fact that approx only 4 BTD are granted every quarter tells you the rarity of it and importance it carries.

Also many times not getting BTD after applying for it gives negative feeling to the market about efficacy of product.

If B-OM gets BTD the SP will go up else it may step flat or go down in case of rejection

[loanranger]

So a Breakthrough Therapy designation would "expedite review accelerating movement through the final phases to approval", include "intensive support and rolling review from the FDA which speeds the phase 3 and can shorten a trial"
and "it adds to a valuation by big pharma for the terms of licensing"

...yet the importance of BTD as described on this forum has been "overblown"? Seems to me it's pretty hard to overblow that drug approval speed and added value stuff.



"What a lack of BTD does not do":
1) it does not prevent a drug from moving forward into phase 3 (Did someone say that it did?)
2) it does not nullify any agreement or conditions for licensing under regular, unexpedited, review and protocols (What agreement? Was there a concern that an unknown agreement that wasn't contingent on a BTD might be nullified?)
3) it will not impact the end-of-phase meeting other than discussing the best path forward under more conventional FDA guidance (Other than that Mrs. Lincoln, how was the play?)
4) it will not make B-OM “dead in the water” because it must go through a more traditional pathway to approval (I think it was the BTD itself that was described that way, not the drug, wasn't it?)