Replies to post #333290 on Innovation Pharmaceuticals Inc (IPIX)

[sunspotter]

"FDA already responded to our IND and that was suppose to be some minor matters to clear it up."

Nah, they didn't.

They responded to the document IPIX submitted for the pre-IND meeting (the clue is in the word PRE).

"November 2, 2020
Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
Brilacidin
Company finalizing Brilacidin protocol; clinical study anticipated to commence in 4Q2020

WAKEFIELD, MA – November 2, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today receipt of written feedback from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company’s planned clinical trial for Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. The FDA response completes the Pre-Investigational New Drug (Pre-IND) process."



http://www.ipharminc.com/press-release/2020/11/2/innovation-pharmaceuticals-receives-pre-ind-response-from-fda-on-covid-19-trial

You might legitimately ask why it took the sluggards at IPIX over two weeks to submit the actual NDA after they had received the FDA;'s comments, though.

It might have been a lot over two weeks as Nov 2 was when IPIX announced receipt of the feedback. It probably took them another two weeks to find the FDA correspondence in the post room after it was delivered.

[StockJumper25]

Pete, agree 100%. You took the words right out of my brain.

Thanks for putting this out there. Very frustrating.

Maybe we get approvals in UK and INDIA before the USA, and send a message.


Go "B" !

[wsbc]

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

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

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.


____________________________________________________________________

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?

[Empiricst1]

Pete, round and round we go. You may recall that I feel there is no "FDA". There are political appointees, right now many of which are lame (but not all), professional staff which are under-resourced, but still mostly highly professional, but who too often read the often poorly designed regs too literally, causing time-blocks when they should be speeding it all up.
Yes, we must stress that the regulations leave lots to be desired (recall anyone can sell ED solutions that don't work, but that are not addressed by FDA, for a relatively small example). After all these years FDA is still a work in progress whose regulations are heavily influenced, if not actually written by drug and equipment manufacturers (often working out of China and India) -- enough said. But it is all we have, and for most products, it works pretty well. Just not now, not with covid and the political concerns, sorry to say. All I'm saying is that we need to recognize the complexity and how it affects IPIX.












fda is still a work in progrerss.