Texting while Sleepwalking
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
here is the zerohedge version of that news
https://www.zerohedge.com/geopolitical/massive-who-study-shows-remdesivir-doesnt-lower-covid-19-mortality
the fda could give permission to start earlier than 30 days once they receive the ind
i noted that in the last PR ipix did not mention Q4 human trials even though they wanted to let us know the fda accepted the pre ind
realistically this is looking like a 2021 trial. With so many holidays during December, it might be a difficult time to start.
what kind of interim results are we looking at? what kind of dosing? how long is a dosing regimen? ipix knew all this info when they released their last Q report. That is how they were able to put a dollar amount on the cost to do a B for C trial. They knew how much b each patient would need and for how long. they hinted in a subsequent pr they will have excess b for other trials (most likely combo trial).
Just keep an eye out for the 5th Brilacidin trial
https://clinicaltrials.gov/ct2/results?cond=&term=brilacidin&cntry=&state=&city=&dist=
Just pulled up an IND app
it states: "I agree not to begin clinical investigations until 30 days after FDA’s receipt of the IND unless I receive earlier notification by FDA that the studies may begin."
file:///home/chronos/u-7747e5cedf79aa10bdd0bff118345832dfd74e2d/MyFiles/Downloads/FDA-1571_R14_FINAL_508_Secured_4.pdf
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-forms-and-instructions
Did the pre-ind meeting happen? The oct 2nd pr said the meeting was granted, but then threw in something about written response received. Was that just to say they received a written response from the fda that that meeting was granted?
Prior to covid, the fda had 21 days to respond to a pre-ind/type b meeting request and then schedule the meeting within 60 days. the pre ind package is due 30 days prior to the date of the meeting or wro. minutes of the meeting are provided 30 days after the meeting happens.
Post covid, what's the timeframe? Other than the completeness of the pre ind package, there is no timeframe like mentioned above. Seeing how we heard back in less then 1 week compared to 3 weeks pre-covid, then i assume things take 1/3 the amount of time... that being said, instead of 60 days to schedule the meeting, it would be 20 days. We are inching up real fast on day 20.
at least we were able to confirm between june and september that only 15 million shares were added to the o/s. considering our current 10 day avg volume is approximately 1.5 million, we theoretically blew threw those new shares in 10 days
bears have been keeping the dilution argument on the DL cause they have no proof other than speculation. if there is a naked short, all the better cause once we appear as a human trial on the fda site, we will get a whole new bunch of investors driving up the price
i remember back when diagnostic companies were being added to databases. it was like shooting fish in a barrel. google each company on the list. see if they were publicly traded and then buy shares. they all went up gang busters.
c'mon IND, let's go
Didn't you have a similar experience with another expert toward the end of September? Again, i appreciate the exposure you and others are bring to B on twitter, but there will be a roadblock when it comes to additional information other than what we have seen via pr
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
According to the ctap dashboard, there are more than 550 drug development programs in planning stages and 350 trials reviewed by the fda. Is B the needle in the haystack? Hope so
won't the pre-print/peer review doc or docs just be more pre-clinical data? seems like we need human trials for anyone to be convinced
i know the headline that R + B basically kills 100% of the virus, but seeing a headline like that can be viewed like a snake oil salesmen pitch. That has been the skepticism here, like if B is that amazing, why hasn't one of the higher powers pushed this drug through the process quicker?
I look forward to the pre-print just so all the characters on the RBL side of this story are revealed. There was word of a 2nd pre-print/peer review coming out of the PHRI, but very little updates have come out of PHRI (or at least they keep Leo in the dark)
Hoping we appear here before end of the month:
https://clinicaltrials.gov/ct2/home
This would keep us on the rumored timeframe
I am in Boca Raton and that is where my family friend is. He literally went to the ER, explained his symptoms, got an exam and was told to go home. That just happened last week. Boca is a place many people from the northeast are about to visit for the winter and the hospital traffic surges. If this is the practice in place now by the ERs, I would expect a devastating winter down here
I am enjoying your new narrative. It's more entertaining and less abrasive.
Background info:
IPIX PR Aug 24:
Interactions with the Food and Drug Administration , through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial.
FDA July 14th CTAP update:
Preliminary, partially-formed inquiries go to them before they are assigned to product review teams to determine next steps for engaging with the FDA, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.
https://www.fda.gov/news-events/fda-voices/update-and-behind-scenes-fdas-coronavirus-treatment-acceleration-program
IPIX PR Oct 2nd:
Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that earlier this week the Company submitted a pre-IND meeting request to the FDA
My interpretation
At the end of August, Leo hints that IPIX is sprinting toward human trials in Q4. We all assume September (at least me) that we'll be getting the big CTAP update stating IPIX has been given the green light for human trials asap. September comes and goes without any human trial update, which is pretty much a let down for all. Upon further frustration, a re-read of the past PR's for the umpteenth time shows that Leo never said an IND app would be submitted to the FDA, but rather "interactions." Those interactions were preliminary (just look at the ctap link provided). Obviously the preliminary back and forth with CBER/CDER experts on hand was sufficient enough to have a complete pre-IND package submitted most likely at the end of September (according to the Oct 2nd PR)
Now if IPIX had it's own twitter account, these could be official updates vs. issuing a PR that has to add a bunch of other information to make it look more impressive other than saying Pre-IND package accepted by FDA with written responses expected shortly. Also a tweet could have gone out in early September that interactions currently underway with FDA with Pre-IND package to be submitted by end of month would have help calm investors nerves and not try to hypothesize what is going on such as did they submit a pre-ind or just go for the ind, did they decide to wait for the rbl to finally finish before contacting the fda, did leo buy a lambo or bently, etc...
At this point, when B for C shows up here, we should see another epic run https://clinicaltrials.gov/ct2/home
The pre-print will be great. I am still not sure if GMU is the RBL because some of the recent pre-prints i have seen out of the 'narayanan lab" in August make not mention of B out of the 22 drugs they are screening. GMU got our EC50 value per their update.... but we are not sure if they are in fact 100% the rbl doing the extensive testing. That was my concern about why the suffolk county dinner party stated that gmu was indeed the rbl... now it could be the rbl who tested b combined with r, but i don't see that update coming out of ipix or gmu.
GLta
I am hopeful for IPIX. I have been involved with otc companies for too many years (actually decades) and only a handful (literally) were "lotto tickets"
When they pay off it's a great feeling. I'm not on the buyout bandwagon yet. As many posters have noted, there are many catalysts and even though people bash the ceo here, i somehow think he's the most anxious of all
i think hospitals and ers need training in handling covid patients. hopefully hospitals are putting patient's health in front of financial gain.
just had a friend of the family, in his 70's, complain he wasn't feeling well. He went to the er where they said his oxygen level was ok and sent him home. Later that evening he had a lung collapse and rushed to icu. If everyone were treated like trump, this would be a more controllable virus, however that is not the case.
The talking heads on tv make it sound super manageable, but there needs to be a rapid overhaul of how patients are treated when showing up with early symptoms and not told to go home and come back if it gets worse... cause it will
just guessing, or using mb logic, since leo was off by a month with the fda, maybe he was off by the same period for the pre-print. let's get a nice santa clause rally here
The only real news is when Brilacidin for Covid shows up here
https://clinicaltrials.gov/ct2/home
The Pre-IND is in the works. you don't submit a pre-IND package with a contingency that the RBL is 'nearing completion'
Pre-prints are on their own timeline for both PHRI and RBL. It even seems as if the grant done back in June is for the RBL and not clinical trials (just look at the June PRs).
New grants were mentioned with the b/r PR for combination trials, but in Leo's words it normally takes 3 months to hear back
As i have said, I appreciate the posters/investors on twitter or in person meetings/dinners making people aware of brilacidin, but if they are just getting the same information that we already have, that just means we are still on the radar. We are a great preclinical therapeutic with scores of others. Based upon public information, seems to be a roadblock of additional information till we get into human trials imho
In summary, https://clinicaltrials.gov/ct2/home is what matters the most now imho
yup. agreed
that's why i am curious if 'in vivo' testing has begun at the rbl... which would mean we received a grant in collaboration with the rbl
I would also assume Gilead wants be back in the spotlight after trump's pumping of yet another therapy.... Leo did say in the 9/15 pr he would pursue larger, government funded combination trials. I am sure the all the anti-Trumpers are also looking to do anything to refute trumps recent praise of the experimental cocktail therapy.
earlier today i asked if there is a way to see if the RBL received a grant to further study B. There was mention of the grant to cover 'in vivo' testing. seems like the pre clinical testing is going further than the RBL and Leo's expectation
actually oct 2nd the company used the phrase "nearing completion" again
Is there a way to see if there is an RBL that received a grant to study Brilacidin 'in vivo?'
From the PR's, it seems the RBL is most interested in pre-clinical data and not pursue their own human trials
Now from IPIX's standpoint, the pre-ind was submitted (basically 1 month late according to the August PRs)
Instead of having vague RBL/PHRI/University collaborators, IPIX has officially named the FDA. They are now playing with fire. I did watch wolf of wall street last night and wondered if anything Leo did was reminiscent of Jordan's actions. The hard sales technique and bending the customer over rang a bell a few times. When Madden sold stock and then Jordan sold stock just to crash it felt all too familiar in OTC land. NOt to digress too much, but we are now with the FDA. I am upset because the timeline was/has been mislead several times on various topics. if we did not get the pre-ind pr, i would be out of here, to some people's enjoyment. Now the carrot is dangling in front of me again and i just got to see what happens.... call me wile e coyote
I keep alluding the a select few. there has been a rumor date floating around for a while now which we are on target for, depending if ipix submitted a complete pre-ind package and has a green light for their IND
it will be close
I agree. I see the filed their eua based on the president's suggestion. Unfortunately his word is mud with covid therapeutics... i am curious to see what the fda does
Seems like there has a slow down with the Covid related pre-print articles coming out. THat's good for IPIX because it should get us more attention as compared to a few months ago when the amount of daily pre-prints coming out were overwhelming
We are with the FDA - CTAP gets answers asap depending upon completeness of the package. Supposedly we have demand for brilacidin from test sites.
There should be a rather significant update this month imho
With all the fabulous anti-Covid headlines and news items IPIX has been producing over the last several months, the market cap barely budged as compared to all the other pubco's out there that sneeze a news item out that sounds like covid, the market cap doubles, triples, quadruples.... etc...
we just need the validity factor here. while IPIX is not a pinksheet, it is on the mid-tier OTC. WE/IPIX shareholders have unnamed sources of information from China, RBL, PHRI, University, Independent Labs, etc... yet never one concrete name has been produced by IPIX. Yes, we all know the June 5th GMU announcment
Fast forward to Oct 2nd. IPIX has been granted a Pre-Ind meeting
Once IPIX shows up on the fda covid clinical trial list as active, it should help bolster the PPS. There are some links in the ibox to the clinical site. The critical person will ask "why not buy the rumor?" Well, ipix's history is self evident of follow through and rumors here are mocked,,, boy who cried wolf. that is why we sit as of yesterday under .25
Based on the completeness of the Pre-IND package and the written responses already received by IPIX will determine our IND timeframe. I look forward to the declassifying of the ipix docs just like russia gate
We are closer to next week now that it's almost hump day
IPIX granted a FDA meeting. We will be apprised on the meeting date? Is there a meeting or will the FDA just give written responses based upon the pre-ind package? i guess we have pro-IPIX government people involved now with the ind process who seem to be a liberty to discuss IPIX on behalf of Leo yet won't disclose details to shareholders.
Almost out of pop corn. Don't want to miss the fireworks
I second those feelings, but apparently it's way more interesting to fantasize along the way. Message boards are for pure entertainment.
I wish the PPS went up as fast as my ignore list
Yes, that is a GMU release that mentions obtaining the EC50 value. The is exactly what Leo told me on the phone. They paid $35,000 to get the EC50 value so they could submit an IND
However where does IPIX state the RBL on their end? It was a hot topic back in June/July but has since died off
Does it state anywhere in the Sept 15 PR that GMU is the RBL? This is a question open to anyone.
Show me the IPIX PR or SEC filing stating such. When I spoke with Leo, he said the $35,000 paid to GMU was to get the EC50 value so they could submit an IND. That also relates to the June 5th announcement from GMU. Maybe I am overlooking it. Thanks in advance
Also, the Oct 2nd PR says: Extensive pre-clinical research, nearing completion, conducted at independent laboratories reinforces the antiviral potential of Brilacidin against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
Food for thought; why has IPIX yet to name the RBL however at the "dinner" last night George Mason is the lab named?
With the above being taken into consideration, the select few seem to have a way around the NDA or whatever is in place of the investment community and Reg FD. It's one thing to go over the previous PR's, which seems to be the case, however I am confused how GMU would be part of the dinner discussion.
I actually explained it once but my post was removed. Unfortunately I am unable to expand upon it. If the admins or mods want to restore that post from maybe 2 months ago, I would be fine with that.
Based on statements made by IPIX via PR: 7
In a likert scale, it's best to use odd numbers to give a person a neutral option (fyi)
I know posters like to pull quotes from other poster's messages, so here is my key point: "My frustration is how the investment community is being handled here vs a select few. IPIX's PR's in August were very clear, yet anyone who questions the timeline is viewed as the enemy here or impatient"
As information starts to go from pm to public, it's important not to set the bar too high
As a point of reference, my call with Leo a while back, as soon as I mentioned message board investment community, he quickly ended the call.
Some of you have picked up on my frustration with how the information is progressing and ipix's reticent stance. I have received supportive messages along with a few snarky comments.
There is more to the story that will come up in dribs and drabs to the public forum. My frustration is how the investment community is being handled here vs a select few. IPIX's PR's in August were very clear, yet anyone who questions the timeline is viewed as the enemy here or impatient.
The only thing that is clear, 60 days later the RBL is still nearing completion. The PRE-IND meeting request was granted to help the company file a subsequent IND " This pre-IND review will help result in a more efficient review of the subsequent IND
submission." - that comes straight out of the May FDA report. The completeness of the Pre-IND determines how fast we get to the IND. Let's hope "nearing completion" won't be part of IPIX's Q&A
I hope restraint will be shown. Let the company do it's thing. I am happy Leo decided to leave Q4 human trials out of his last PR, however the sales pitch was still provided "Given such interest in Brilacidin, the Company anticipates the planned COVID-19 trial can be rapidly recruited and completed."
Now that we are in front of the FDA, let's see what IPIX updates come out.
just a month behind schedule. trying to find a realistic timeframe for pre-ind fda response. best answer is that response times vary based upon completeness of pre-ind package. let's hope the extra month wait was well worth it. did today's pr mention ctap? from other companies/examples i posted in the past, it approx 1 month from pre-ind to ind and then another month from that point. each ind applicant will be different, but that just seems to be the general timeframe. i noticed Q4 human trial start date was also missing from the pr. seemed this update would have been best as a twitter update... which one of the fake twitter accounts wants to post it?
that being said, the flippers see this and know we have another 45-60 days before the potential fireworks.
June 5th there was a PR stating GMU received $35,000 from Innovation Pharmaceuticals to study brilacidn to come up with certain values.
Why can GMU make that announcement?
Why hasn't IPIX make that same announcement?
Why is GMU updating the medical community on other major updates, yet we get a 'read between the lines' PR from IPIX as to when it's combined with Gilead's drug, that it basically destroys Covid as if never entered one's system?
Need an example: https://www.biorxiv.org/content/10.1101/2020.08.12.246389v1.abstract
I have already stated Chimeron Bio and Emergex yesterday
Is Brilacidin top secret? I can see why the longs who have been here for several years get upset at new, anxious bulls that ultimately get let down by a company that has a habit of releasing exciting PR's with no follow through.
Just pull up the August PR's and don't taunt me with rhetoric
Yup, looks like i am becoming one of those longs who are not willing to believe in reading between the lines is what is actually happening. Blah
i have whatever preprint servers when it comes to covid updates saved as favorite websites. i am keeping the faith but ipix's way of updating investors has me concerned. As much as i love the PR about the R with B basically eradicating Covid, the stock is actually trading lower then before that announcement. My stinky pinky threshold is about to get hit.... yes i know ipix is not a pink, but it trades on the otc. in my book, that is the same thing. limited oversight with big, forward looking statements
BM still at 933. If you link back my post, it will go to the day we finally broke resistance and hit 943. Unfortunately the reticent stance from IPIX gave up the momentum. Fingers crossed Leo discloses what is holding back any further updates. July and August IPIX couldn't seem to hold back their excitement, yet September, the month that was set up to be the make or break month, failed to deliver IMHO
yes. i don't know why that it is a big mystery or shock. when we had a resident pumper on this thread, he gave the phone number and said to push the option for ceo. why now question me and not all along? Is it because i can't post high hopes for an update and now that the time frame has passed I can only bring up doubt? i was very optimistic that we would hear by mid september re the grant submitted back in June. I am sorry that i hit some people's nerves on this board. HOwever the grant was submitted back in June. It's now October during a pandemic when things meant to address the pandemic are sped along. and the ceo gave me the 'mid september' time frame. Oh well
BM down to 933
Leo said CTAP, not OWS
I guess we'll be finding out soon enough. Looks like September is a lost month for significant update. Not sure what happened to the grant Leo said we would be hearing about in mid-September on my phone call with him. Maybe he should start under promising and over deliver. He is doing the inverse which is not good for morale
May Brilacidin be brought up at tonight's debate and the stock opens above $5 tomorrow. I am all for this being legit and there is a mass amount of work being done behind the scenes. Let's just say B for C just ends up being another promising candidate but goes by the wayside, there are still other indications that can grow IPIX by leaps and bounds.
My numerous posts just now have to do with IPIX being clear with investors as to Brilacidin for Covid and nothing else. May everyone make big bucks on their investments and stay healthy.
Fingers and toes crossed for a big bang this week
I am only saying other companies were able to mention their relationship with GMU. We know there was a June 5th IPIX/GMU tidbit of information. Why was the bit of information allowed to be discussed then but IPIX not be able to 'return the favor'
it's really a hard topic to discuss because it could be any number of things which can't be proven. that's why it's not worth discussing. Bulls have the NDA (or similar document) argument, yet there was a June 5th PR.... and Bears can come up with any number of reasons why IPIX doesn't say anything.
I was thinking about the new hire. Do we know if the new hire is for B? Wasn't there a PR stating UC? Yes, July 7th "“Concurrent to the Brilacidin IV solution manufacturing for COVID-19, we are refining drug formulation plans in preparation for a future planned Phase 2 clinical trial of oral Brilacidin in Ulcerative Colitis as part of our larger IBD Program."