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Replies to post #333326 on Innovation Pharmaceuticals Inc (IPIX)
Pete... you seem to be confusing the PRE-IND component with the IND component, based upon your post.
Our IND wasn't submitted previously, and hasn't yet been submitted. Only the pre-IND package, to which a 'written response received' by the FDA was announced.
Just because people on this board make assumptions that things like the 'IND was submitted', doesn't make them so.
I'd been saying for weeks (literally) that the IND hadn't been submitted yet, and nobody wanted to listen.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/pre-ind-consultation-program
Quote:
Note: Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview
Quote:
An IND application may go into effect:
-30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
-on earlier notification by FDA that the clinical investigations in the IND may begin.
This timeline is what matters currently for here in the US and getting a domestic trial moving.
Overseas, no IND or FDA approval required to get things moving, so overseas will likely lead, since getting this IND package together and submitted seems to be a colossal hurdle for Leo.
Additionally, there have been tons of posts on here related to the IND/Pre-IND process over the last several months.
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My view of FDA remains that they are a bunch of friggen' dolts.
Even in grade school teachers are quick to note the fast learners and put them in accelerated classes.
But FDA, unthinkable. Put every drug in the same line and they all go thru the same wait, wait, wait BS (of course payola moves you to the front of the line, especially for grants)
FDA already responded to our IND and that was suppose to be some minor matters to clear it up.
One would think you don't resubmit the IND, you just advance the old IND with the corrected minor details so an OK could come about nearly immediately if all matters squared away. But then if we don't have 10 levels of oversight and signing off, we don't have the layers of govt employees needed and the passable deniability to cover those that slow things down for payola or should something amiss happen with a drug. Sometimes the amount of waste in these govt departments and agencies and all things they do in general is beyond even one's wildest imagination. We'd be a lot better off to pay all Congress members $5MM/yr if they would just play fair w/ the American public.
IMO the only saving grace for IPIX is the overseas trial that will put Brilacidin CV19 on the news worldwide. Otherwise, I could see BP winning the day in the USA and burying the small startup with the treatment that will cut them a new one.
I hope IPIX goes w/ a foreign BP and tells US ones to stick it as to the best drug to come down the pike.
Since this started, seems like big medicine is as rigged as Wall St. Oh yeah, they pay big lobbyists as well. Who da thunk?
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11/17/20 8:55 AM
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