Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

TIAB, it all depends on the structure of a deal. These are typical

1. Total process takeover by a partner --> IPIX hands over development and commercialization.
2. IPIX responsible for development up to and including marketing application. Partner takes over at commercialization stage and may provide expert support for development and marketing application.
3. Partner takes over development and future commercialization but IPIX supplies the drug for development phase and possibly for early commercialization

I have seen mostly cases 1 and 2, some rare cases of 3. In cases 2 and 3 a sane partner would require FDA approved and trouble free CMO for manufacturing before signing the deal and Dr Reddy, for certain, is not it.

If there is a partnership deal in the works it would probably be something like case 2. I am basing the guess on the current activity by IPIX. If there is no deal to be had and Leo's has decided to go alone IPIX would still need to address Dr Reddy's non-compliance situation ie. get trusted CMO. FDA will inspect plans and possibly facilities for manufacture, storage, distribution and administration of an experimental drug before giving a go ahead for a P3 trial - Dr Reddy might make FDA to balk.