Replies to post #369206 on Innovation Pharmaceuticals Inc (IPIX)

[ROMAD Diver]

Again, I agree with you. Right to Try is definitely an option--right now even. But it will need to be the patients who initiate the Right to Try in concert with their medical providers. I guess Leo can put out infomercials to get the word out to the public. Is there still airtime available for the Olympics? :D

[wsbc]

Insanely difficult for me to imagine anything resembling an EUA for Leo without a partner. He would need massive manufacturing and distro to be in place and would need to demonstrate this.

A BP would easily be able to facilitate this.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#conditions

4. Additional Conditions of Authorization

FDA, on a case-by-case basis and to the extent feasible given the circumstances of the emergency, may establish additional conditions that FDA finds to be necessary or appropriate to protect the public health (section 564(e))52, such as the following:

*Distribution and administration — conditions may be placed on which entities may distribute and who may administer the product, and how distribution and administration are to be performed. In addition, conditions may be placed on the categories of individuals to whom, and the circumstances under which, the product may be administered. FDA anticipates that distribution and administration of EUA products will be performed according to existing official government response plans, as practicable and appropriate. In some cases, administration of an MCM may go hand-in-hand with dispensing the MCM. In establishing conditions with respect to the distribution and administration of an approved product for an unapproved use, FDA may not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.

*Advertising— conditions (e.g., limitations) may be placed on advertisements and other promotional descriptive printed matter (e.g., press releases issued by the EUA sponsor) relating to the use of an EUA product, such as requirements applicable to prescription drugs under section 502(n) and requirements applicable to restricted devices under section 502(r).

Running a P3 concurrently would be prudent as well to move towards full-approval.

If I were running the show, I'd also initiate a P1 nebulized after a reform with some of the upfront capital to continue to move the chains.

https://www.ncbi.nlm.nih.gov/books/NBK53122/ (interesting EUA info here and perspectives)

We have no updates concerning anything leveraging gov't resources on the partnership/support level either, which is strange. Defense Production Act could be an option, if memory serves... for manufacturing and distribution. DOD has programmes in place as well that can bypass all the nonsense related to the acquisition of products. Direct and immediate funding without oversight. This is how Pfizer got their $1.6B initially, through a backchannel with ATI.

Leo's been informed of this, and I'm hoping he's using all available resources to move this with all possible haste.

Right to Try an interesting option for Leo...They can file an application for FDA emergency use... Doesn't hurt if they have the RBL tests alongside P2 data and previous B trial info. The Right to Try is interesting for those that are severe...