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I was pleasantly surprised by the clinicaltrials.gov update. I'm interested to mark whether IP continues regular and granular updates.
Goes without saying, I'm hopeful Brilacidin hits the mark.
Clinical Trials, in response to an Innovation Pharmaceuticals' Friday 3/5 submission, updated site information before 6am Monday 3/8. Can't say that's the norm. I've not read any guideline that details CT's update cadence.
I believe this link references the concern: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
Synergistic concern. Never administered in combo. Each day concern lessens.
I do agree that IF there were a significant AE it would be quickly identified. Also, like you, believe we are past initial dosing and therefore past potential unexpected response. Each day I grow more confident.
There’s real risk first days, then expanded and accelerated dosing.
GLTA(Longs)
Clinical Trials site updated to add 8th IPI Site, Russia.
https://clinicaltrials.gov/ct2/history/NCT04784897?A=1&B=2&C=Side-by-Side#StudyPageTop
Touche'.
As many as have a dictionary. (Just joking Rocky. Glad you made it through COVID)
This idea constituted part of my email to Dan. "There are no therapeutics.", really means, "We (BP) have no therapeutics." Pharmaceuticals flood reporters with curated information. Its not necessarily untrue but its by no means complete. Writers take what is provided and think they've been offered the full picture. I hope Dan takes the time to review the body of Innovation Pharmaceutical info I provided. Combined with a chorus of support from others he'll get a symphonic experience versus the one-note jingle provided by big pharma.
That's how I read your post. I was hoping to make it easier for others who might follow the lead.
Dan can be contacted at: dan.vergano@buzzfeed.com
I wrote to the author. Provided half dozen links and bullet points. I let me know there are therapeutics in development (and not pre-clinical). He wrote back within 5 minutes. Said he'd look into the info provided.
Great to have clarity. Thanks.
I emailed him a couple of hours ago. He replied immediately. Hopefully he takes your info and mine and finds his way to a story.
I don't disagree. Farrell90's interpretation seems to be more logical and applicable across multiple sites and two countries. I welcome his insight.
One significant point I failed to make in my reply to Farrell90; I interpreted an extension of regimen from 3-5 days as a good sign. An indication that progress was being made, no AEs were apparent and continuing Brilacidin IV was seen as the most expedient path to recovery.
If I read Farrell90 correctly he interpreted the extension of treatment as a sign Brilacidin was not demonstrating positive results, that additional treatment was necessary to garner positive results.
This difference in interpretation is what I meant to use as an example of "we being smarter than me". I read it one way and went merrily along. But Farrell90's interpretation is equally valid.
Its an illustration of how results and data can be interpreted very differently. This through the eyes of two who support Innovation Pharmaceuticals' efforts.
Its great to get alternate "reads" of the Clinical Trail protocol. I am left questioning whether a decision to extend treatment from 3 to 5 days will be made on a participant by participant basis beginning immediately or after interim data analysis has taken place. And if post-interim analysis will inform a protocol change from 3 to 5 days on a case by case or global basis?
I lean toward regimen extension (3 to 5 day), being made on an individual participant basis. Whether this evaluation is being made beginning with subject 1 or after interim data review remains, for me, to be seen.
But the we is much smarter then the me. And Farrell90, your interpretations have been bright stars on the board for some time. So, I wait, like everyone, to see how things play out.
GLTA(Longs)!
Bravo. Clear thinking, practical wisdom, empathy in practice.
Sell and re-time your entry Traders. (Good luck and don’t miss the re-entry.)
Work your position shorts. Hedge and reconfigure your position before June. (And hope good news or interim data isn’t leaked before you’re optimally positioned.)
Longs, you’ve been patient. The time is rapidly approaching for your reward.
GLTA(Longs)
I hope you had an opportunity to read my reply.
GLTA(Longs)
Too true.
Live and learn. ( without resentment or drama)
Regulatory requirement: study (If inclusive of US sites.) must be registered on Clinicaltrials.gov no later than 21 days post 1 participant enrollment.
It will surely be posted by the close of biz next Friday. I believe it will be posted by Thursday next week.
( regulation can easily be found on clinical trials.gov or read more detail on r/IPIX)
I’ll be whistling those tunes all the way to the bank. Thanks.
I’ve never known you to run from a question. I’ve always thought you posted well written and articulate positions, worthy of consideration. And when I ask that lay out your position, complete your statement...magic my post is gone.
Telling.
I would like to highlight a particularly important sentence from today's PR. For those speculating; "Has it started, are patients being dosed?".
Excerpt: Patients are being treated, with recruitment and enrollment progressing at trial sites.
Innovation Pharmaceuticals has made it clear for those who are open to listen and learn.
Existing indications repurposed to battle COVID-19 continue to come up short. It may well be that a first-in-class HDP, Brilacidin, is needed to defeat the newly emergent causative agent of COVID-19.
Emerging disease, meet emerging cure, Brilacidin. And we’d love to introduce Brilacidin to your friends.
For purposes of comparison and calibration: the GSK study NCT04376684 was first posted to CT.gov on May 6th, 2020.
Phase 2.
800 participants/130 study locations.
Primary Outcome: Proportion of participants alive and free of respiratory failure at Day 28.
I’m afraid what you are suggesting confirms a French Connection fails to pass the smell test.
If/When documented engagement by a French pharmaceutical company occurs I’ll be sure to post info and links. (Punctuations included.)
France? Please elaborate and provide links to substantiate.
It is tragic. And exacerbated by a market that rewards profit above development of new and novel drugs. The structure of a market that discourages investment in high risk, low return indications is a shame. Permitting manipulation and overt attacks against companies introducing novel treatments is reprehensible and criminal.
GLTA(Longs), good health to all infected, goodwill to those who would risk careers and capital to bring new hope to mankind.
Sorry, mis-stated the reformulation target. UP/UPS application recipe has been reformulated and successfully tested in a Ph1 study.
Agreed. Too much froth in the previous weeks. Too many players trading stonks. (For Christ sake, did you run out of cat videos and stumble on YT’s How to trade and get Reeoch?)
Innovation Pharmaceuticals is in a great place. B-COVID-19 underway, cash on hand, UP reformulated and ready for PH2, B-OM ready for Ph3, targeted time-release B-IBD poised and RBL’s membrane disruption verdict forcing memory to cast back to ABSSSI with wonder.
Brilacidin is a tasty platform.
A picture worth a thousand words and a post worthy of pilfering.
Leo has often stated his intent to take as many indications as feasible into or through phase 2 in an effort to validate Brilacidin as a platform drug. The pipeline progress chart sure looks like the fulfillment of that strategy. Next step, monetize.
Seems awful quiet.
We stepped into a short left hook.
From 2/16/2021: Consider the date range to be reported in this 10-Q. A period of preparation and planning. Set-up not knock-out. The commentary, the anticipation, being created is a bit on the frothy side. This 10-Q may very well be cut and dry boredom. I'd like revelations but I would not invest too much hope in the bounty of a quarterly report.
Bulls are looking for a KO. Be wary of the counter punch that will land if the 10-Q fails to deliver the 10-count blow. Solid footwork wins championship belts.
GLTA(Longs)
One anonymous poster references a cryptic post from a second anonymous poster. Validation doesn’t get any stronger than this.
GLTA(Longs) I suspect players are calculating and recording loss this morning while resetting for an anticipated run up. (Well, that’s my sunny pov.)
I think that theory is very good. A PhII converted into a PhII/PhIII would require the, very, extended timeframe.
Thanks. That's one hell of an extension to end date. Almost too much to be believed, particularly for the COVID-19 condition. A PHII/PHIII modification? Based on positive early results?