Replies to post #338494 on Innovation Pharmaceuticals Inc (IPIX)

[snayeman]

Serious question to anyone, with only 120 patients needed for this trial, why is there a need to spread it out over multiple sites including overseas! Wouldn’t it be much easier and quicker to focus on just a couple sites given that there is so many patients everywhere!

[dp70]

Great post. IMO from chart perspective news imminent (FM conjunct chart Mercury).

[capital gain]

Happy New Year JFM, great post and great future for IPIX

[loanranger]

""Overseas" jurisdictions are said to be easier (bureaucratically) than U.S. FDA, and it was reported in PR we got the IND/FDA. Also consider that the company isn't required to report everything as it happens...I believe it has 21 days to report such an event. So has it happened? Has 21 days passed?"
21 days to report the conduct of a trial in a foreign country? Report it to who(m)? Not the SEC. There is nothing that requires reporting to the SEC for which there is a 21 day deadline.

[frenchbroad]

There are more news from the important New York dinner? Sorry if I miss. I watch close for all the person that learn of Ipix and Brilacin at this big dinner.

[Blue Fin]

Interesting post JFM: "I believe the 21 days is the reporting publicly to the Shareholders of a material event after it occurs...NOT THE SEC"

[Billy10us]

Hi JFM Happy New Year I sent you couple of private emails and I suspect it may have gone to spam.

[Rdunn88]

When did Russia become part of Europe? Why would Leo or anyone want a trial in Russia when we don’t validate medications from there? Lol

[dreamer0]

Thank you! Happy New Year to you too, JFM!

Well said and I agree with you!

As usual, Russia always craves for that 15 min fame. Anything comes out from Russian health ministry is questionable (CV related). They once had great scientists/ virologists etc. Some of them were sold to the highest bidder. Luckily, few scientists were offered a new life and a job here at home rather than these scientists helping bad apples (Iran/NK/China) for doomsday event.

Controlled release of info as deemed necessary...for any number of reasons ..leverage/vantage point?

At this point, what really matters is that we have a GO from the FDA to initiate/run CTs and on the same note getting a green light either from EMA/RoW shouldn't be an issue at all. Running CTs in bad apples domain is a last resort?:)

We (longs) have waited long enough n 2021 will be the tipping point for all entities*!

*Entities: Patients; Research/Scientific/Medical community; IPIX SH; Other's

[LilyGDog]

Another great post. Thanks JFM!

Go Leo & IPIX!

Dreamer0...Happy New Year

re: trials

... lots of speculation on the Trials...as to where IPIX is and what has been done and/or when...and on a totally as separate matter, the speculation on the drug source of reported Russian (alleged)"antidote".

IMO..."controlled release" of info is intentional.

I prefer the dribble of PRs as events happen in real time... But, there are those shorts who take advantage of short PR's, twist them and/or intentionally undermine them, questioning why there is not more information (in the form of Strawman questions) especially from this board (though I am told he does not read)...It's easier to question and dance on a short PR. I am not implying that is the reason, but perhaps Leo is looking at the most "impactful" PR to form a tapestry of Brilacidin's value.

IMO...bigger things and players are likely in play, as has been referenced in prior PRs and might be considered in the roll out of PRs.
The Question of whether IPIX has received a CTA from an "overseas" eastern Europe country (Russia, as discussed here before)...is an interesting one. "Overseas" jurisdictions are said to be easier (bureaucratically) than U.S. FDA, and it was reported in PR we got the IND/FDA. Also consider that the company isn't required to report everything as it happens...I believe it has 21 days to report such an event. So has it happened? Has 21 days passed?

Few would dispute that "now" is optimum time, and should be for several months, for recruiting CV trial candidates EVERYWHERE in the world...IPIX/CRO is or will likely have an easy time lining up sites previously screened, recruiting the candidates (if it has not already been completed).

I could see Leo waiting on reporting events (within 21 days of occurance if he lining up all completed thresholds he wants to accomplish for B, for its next phase of development, while he/CROs line up Covid-19 CT (and the other indications progress, which have been alluded to in previous PRs) on which he indicated he wanted Brilacidin to move forward.

IMO...in the next one to three (several) weeks we should see Brilacidin will blow away the competition as a Therapeutic ...at which point IMO IPIX should start going beyond the "serious look" phase to "serious actionable interest" phase by BP especially if we get, as cited in previous RP, movement on Brilacidin for the other indications PR'd (OM and UC.)

Perhaps the plan is letting it all rip at once with a MOA PR's...as there appears to be a lot that is or could be happening!

IMO, speculation about the Russian alleged "antidote"...as being Brilacidin...is likely misguided. As noted by others...the PR references the Russian gov. as "developing" the "antidote", (imo best they could be doing is to make a feeble attempt to take credit for Brilacidin...post trials..LOL) But, imo, even more misguided is believing they have one, or one that is 99% effective (or even 10%) effective.
https://112.international/russia/russia-promises-to-present-covid-19-antidote-57775.html.

If we look at the Sputnik vaccine "success" we can likely guess what the truth success of the supposed "Antidote" is and will be.

My personal GP happened to graduate from a major State Medical University which is a top medical university in Russia. https://fmsmu.com/about-university/...he has had conversations with some former colleagues in the hospitals...and told that the vaccine wards are empty. Few are taking it...few believe it works... It appears that is so because there is likely no anecdotal (or credible scientific) evidence in the street.

If we measure the success of the Sputnik Vaccine's by the credibility response of the Russian population...it is an utter failure. (likely does not work...but Putin, in his own mind, has to look like he's beating Trump...LOL)
https://www.npr.org/sections/coronavirus-live-updates/2020/12/24/949943260/putin-promotes-homegrown-covid-19-vaccine-but-most-russians-are-skeptical

Some further interesting development there is that Russia has been accused of underreporting cases and deaths by 2/3rds of official report...meaning they are 200% more or 3x that which has been reported...sounds like a crisis greater than the U.S and China (under-reporting by 10X).

Know what you own!



ps...before it is raised here...regarding credibility of "overseas" Clinical Trials..(from prior conversations with a 20+ year research MD who has run extensive overseas trials for 4 BP) it was explained that when internationally reputable CRO's supervise and run trials the "overseas gov." or the site hospital staff do not control the trial...they "facilitate" the order under direct supervision of and chain of custody controls by CROs ...identifying the right patients, using the equipment specified and sending it to and receiving it at the site etc is all controlled by CRO. Those CRO's establish the integrity of the trial...if they screw up...they don't get paid...a good incentive for getting it done right!

Full disclosure...I don't flip nor sell. I just add with each PR or as SP opportunities present itself.

[sunspotter]

Only about five factual errors in that otherwise excellent post.

Starting with the nonsense about CROs. There are real experts posting on this MB so no need to rely on second or third hand information apparently gleaned from an MD who has “worked with 4 BPs” in the past.

When I’m less busy being on holiday I’ll try and correct some of that misinformation although I fear it is a Sisyphean task.

[Empiricst1]

Justfacts, as a corollary to your extensive post, let me add this: The European Union has enacted a tougher MDR (Medical Device Regulation) which will no longer accept the FDA findings on products. They need to be reviewed on their own merits in accord with EU MDR rules. This does not apply to pharmaceuticals, at least for the present. It kicks in next year, having already been extended one year. Part of the reason for this action was the importing into Europe of a number of American products (e.g. bad heart stents) that were made in China and other places with insufficient concerns for product failures. In effect, the Europeans said "enough is enough."

I attached one of the EMERGO postings as a background. The MDR documents are extensive and complex, but appear to be less time-consuming in reviews than many FDA practices. Just my opinion. I now work part time as a consultant for a small company helping firms get their products approved to sell in the EU. Each review took about 20-30 cumulative hours to do the MDR compliance (Then that same amount of time, more or less, to do an article for a peer reviewed journal. My estimate, as we are just now starting doing the articles). We have a stud who used to do FDA study monitoring, or the time invested would have been larger for each MDR.

I put this ton of words out just to stress the EU is getting more strict in its medical product reviews, no longer acting as second stringers to the FDA. I am guessing this attitude will be reflected in pharmaceutical product reviews too, as time passes.

https://mail.yahoo.com/d/folders/307/messages/AKIKL8F8jzDFXwXhpQbZ6BfZdKs

[sunspotter]

I promised to outline some of the many errors in your post concerning the roles and responsibilities of the CRO in clinical studies:

Here's just a few:


1) "CRO supervises ALL aspects of trials...from strategy, to regulatory compliance"

No. The responsibility for every aspect of the study rests with the Sponsor of the study, in this case IPIX:

"Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols"

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.3

The CRO is contracted (the clue is in the term Contract Research Organisation) to perform some of these aspects for the Sponsor, but the Sponsor remains legally responsible for every aspect of the study - the CRO can be audited by FDA in its conduct of the study, but any findings are applied to the Sponsor as it is the Sponsor's responsibility to ensure the CRO complies with all necessary rules and regulations.

2) "They also interact with the FDA re: compliance with the trial requirements...and validated lab results done in U.S."

Actually they can't. All these matters remain the sponsor's sole responsibility. They can and do prepare documentation for the Sponsor, but that's about as far as it goes.

3) "If CRO does not perform according to their function...they do not get paid. Great incentive to do it right."

Worded so vaguely as to be meaningless, but essentially if you're Pfizer, AZ or GSK you might get some kind of rebate if things don't go to plan.

OTOH if you're IPIX you pay most of the costs upfront, with a few downstream milestones and the contract has so many loopholes for the CRO to worm through they'd have to completely screw it up to give any kind of refund.

I've signed literally dozens of such contracts on behalf of my pharmaceutical employers, so I know whereof I speak.

Other than those gross factual errors (and a few others) your post was spot on.

[Billy10us]

sent a reply 3-3-21 via personal email regarding ipix, perhaps a problem with spam. let me know

[roiresearch]

Like I said, WAT

I know you a firm believer in IPIX

What I see is a pinksheet stock and Rule 504D in conjunction with recent SEC filings

Once I see the ethical obligation to the medical community to register the study, the WAT will have been proved incorrect. That's it. No need for insulting comments