Texting while Sleepwalking
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i love the parting thought
it's what stratton oakmont was good at
Questions I have based on the pre-ind and written responses received
IPIX: In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
1) what was the FDA recommendation
2) is IPIX in agreement with FDA's recommendation
These are 2 very strong pieces of information left out of IPIX's PR that would have given investors the insight as to when human trials will begin
here is an example of a pre-ind pr that gives investors direction
https://ir.qualigeninc.com/news-events/press-releases/detail/38/qualigen-therapeutics-receives-positive-pre-ind-response
here is an example of a pre-ind pr that leaves investors in the dark
http://www.ipharminc.com/press-release/2020/10/2/innovation-pharmaceuticals-announces-pre-ind-meeting-request-granted-by-fda-for-the-study-of-brilacidin-for-the-treatment-of-covid-19
so did the company definitely proceed with the IND for Brilacidin/Covid? Kind of misleading since the IND process is different for covid therapeutics.
"The request for the pre-IND meeting follows the FDA guidance issued in May 2020, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.”
http://www.ipharminc.com/press-release/2020/10/2/innovation-pharmaceuticals-announces-pre-ind-meeting-request-granted-by-fda-for-the-study-of-brilacidin-for-the-treatment-of-covid-19
I hope you are right.
hahahah... if the company pr'd the pre-ind, they would pr the ind submission (IMHO)
also, the company has pr'd (several times) that the rbl is nearing completion.... they have yet to say the rbl is done
from what i have seen other pubco's do via pr, it takes around 30 days from pre-ind pr to an ind pr.... then it's the nominal 30 day waiting period unless waived by the fda at their discretion
my kids have been in school since early September. They are private too. Pretty much has the same set up. There have been less then a handful of scares between the 2 campuses, but no covid cases yet.
My fear is holiday because that means older generations who are more vulnerable to dire covid then school kids. we have had family friends get covid with kids, but they all have overcome it
It's the seniors and those family members with underlying conditions that will let their guard down during the holiday, especially thanksgiving. the election will be over and people will want to talk about what they are thankful for (usually family).
I am fearing the new year. the best trade will be going long the vix mid-november and see what happens over the next 6-8 weeks (seeing how the virus takes up to 10 days to show it's ugly face)
The FDA is allowed to waive the 30 day period from the time they receive the ind; but that is the fda's call
My point was getting a message out to MSM that the US has similar compounds. For reasons unbeknownst to me, or anyone else here, why do Brilacidin PR's not get this type of exposure. We have seen the same info basically come out via PR already from IPIX about inhibition of the virus.
With a major US holiday coming up in November followed by global holidays in December, the spikes we are seeing now are nothing.
As I watch the call from the top to wear masks 24/7, how do you attend a holiday party and keep your mask on? Will there be no turkey at Thanksgiving dinner? Does everyone have the luxury of plexi glass shields in their dining rooms to keep family members from sharing their germs? Will each person be served a pre-made holiday plate to ensure no germs are passed with serving spoons or the more laxed relative just using their silverware to grab some extra stuffing or cranberry?
How many events have you attended since masks became so prevalent that the only way to endure the event is by removing your mask to eat or drink something? We can all try to limit our exposure, but that does not prevent it. With global holidays coming up, even Halloween quickly approaching and parents just wanting their kids not feel like prisoners, how is there no way to avoid the inevitable, spreading the virus on a mass scale like we have yet to see?
thanks. i had a feeling it would have been discussed previously.
giving linkedin a quick glance
is jane harness an employee at IPIX? it's not listed on her work experience. it does look like she was at Novartis the same time as Erica. Jane is probably how Erica wound up as the latest trial manager.
I would say we are a week away from getting an IND update (if proceeding). Seeing how ipix said there was great interest from hospitals wanting to participate in a brilacidin trial, i can't see how the ind won't proceed
ipix makes itself an easy target by ignoring investors. we should all be able to shrug off things we don't agree with on the board. i have read the expression 'agree to disagree' very rarely here. imho there is a very limited audience reading this thread. hopefully when bigger and more significant news comes out, all the back and forth will be buried with the ipix newbies flooding this thread.
we know all the players on this forum.
i am not sure why i am getting under your skin. you should have just said malarkey.
name the cro
name the cdmo
show us the letter where the fda granted the pre-ind request
update us on the rbl 'nearing completion'
can't we all just get along?
I'm hungry. Serve the cake already
If a GMU researcher updates her social media profile with information about testing Brilacidin against Covid19, there would be an internal problem at GMU letting their staff know to keep it top secret (nda in place). The researcher could easily have just said "During the COVID-19 pandemic, I have been evaluating the efficacy of host defense protein mimetic, Brilacidin, against SARS-CoV-2" and have just left B out of the profile
i admit i am confused. my message will flip flop between bull/bear.
i want to believe but i also want to be realistic and not assume something is going on 'behind the scenes' because B is top secret
If that's the case, anyone who believes that is guilty of murder for each and every person that has passed form Covid 19 since B for C came on to the scene
This is why i am confused. The PR's have strung me along to believe but action is louder than words.
Name the CDMO
Those results are in vitro. WE haven't even hit the in vivo stage
This is a reason why we can't even go the Barda route as in vivo is a requirement now. Leo confirmed Barda wasn't an option on my call but there were many other funding opps to chose from. He said based on the normal timeframe we should have heard by mid-September. It's now late October. Based on that comment, it doesn't seem like we are making it to in vivo through the RBL
Ipix was granted a pre-ind meeting but doesn't mean our journey will progress into an ind - leo finds the pen mightier then the sword (ipix track record). Many pinksheet, i mean otc ceos when pushed will tell you they went public to tap the markets. No better way then to keep dangling a carrot infront of investors
At least i need the write off by end of year if this doesn't pan out; can't believe i am saying this after all the pr's
R fda approval is good for B.... only if B has a combo trial with R
IPIX is so far behind all the major players in terms of getting B approved for C through human trials
I find calls for compassionate use at this point humorous since no one has any more information on B for C than has been disseminated to date via PR - no one is going to be the guinea pig for B with promising in vitro results. There are so many other therapeutics out there claiming similar things to B in preclinical phases; even the Degrado pr hinted at this but the fact we are a synthetic makes us different. That's not a good enough reason to chose B over any other preclinical therapeutic
I was just talking with an ER doc from NYC that moved down to Florida and he was saying covid is just like the flu where someone would need annual covid shots just like the flu shot to prevent that year's strain of the virus. this is where therapeutics will shine, but something has got to give here
let's see how it goes. i will buy more the end of next week. i have not purchased shares since my original trades a few months back. That means either there will be an ind early November and we all make big bucks or the stock tanks because i am breaking my own investment advice. at least we'll know by thanksgiving (because the world revolves around my trades) LOL
it seems like the story is morphing as we go along. i wouldn't be surprised if all the sudden the peer review doc will be once in vivo testing is done... which seems dependent upon a federal grant we did in collaboration with the rbl (most likely gmu)
maybe there just won't be a pre-print made available before the 'in vitro' peer review paper is complete and made public
it would be lovely if ipix took on an IR firm to handle investor questions vs. our conspiracy theory thread
I still find it odd IPIX is the only entity not to name GMU
GMU named themselves in that june announcement
We have had 1 or 2 GMU people state they are doing studies on Brilacidin
I think the peer review doc might not happen
However Leo claimed the pre-ind meeting was granted with the FDA. Clock is ticking
I get the feeling RBL is going to perform in vivo testing now and will be releasing the peer review doc next September
meanwhile, still showing 4 studies at the fDA for Brilacidin. C'mon #5: https://clinicaltrials.gov/ct2/results?cond=&term=brilacidin&cntry=&state=&city=&dist=
Today's fda meeting is going over vaccines, not therapeutics
i would suggest doing a cancel and replace order. if your broker does not make a market in ipix, they are an agency trader. usually agency traders are old school traders on their way out to pasture and care more about socializing on the floor then doing their job. worst case scenario, you need to call your local branch to nudge the floor trader to fill your order. no reason it should not fill with the selling pressure today (trades at the bid)
so all your stocks are meeting with the fda right now? wow, what a coincidence
from my experience, it's about 30 days from a pre-ind PR to an ind PR
There looks to be another 1-2 weeks before an FDA update. I hope at that time brilacidin has study #5 show up on the fda clinical trials list
if it unfolds, i would expect a pretty decent pop but will be followed by an update in regards to the shelf offering. so far, it would seem as if investors are baggage that come along with running a public company imho
remove this and the pressure will be lifted off the pps
https://www.sec.gov/Archives/edgar/data/1355250/000147793220004523/ipix_424b5.htm
ipix has this in place but has not tapped it. most companies would have let their stocks run before putting an anchor around it's pps. lack of grant to date let's one come to the conclusion this will be tapped
anyone who gets upset by this need to sell and not take it out on me.
DD Links
Wake me when trial #5 for Brilacidin shows up here:
https://clinicaltrials.gov/ct2/results?cond=&term=brilacidin&cntry=&state=&city=&dist=
A few pre-print servers in the event a peer review article is released on Brilacidin for Covid19
https://www.biorxiv.org/search/brilacidin
https://www.medrxiv.org/search/brilacidin
https://chemrxiv.org/search?q=brilacidin
Google Scholar search Brilacidin since 2020
https://scholar.google.com/scholar?as_ylo=2020&q=brilacidin&hl=en&as_sdt=0,10
Corporate Update page
http://www.ipharminc.com/newsroom-1
OTC markets profile
https://www.otcmarkets.com/stock/IPIX/profile
NV SOS business entity search page (keep an eye on a/s)
https://esos.nv.gov/EntitySearch/OnlineEntitySearch
IPIX filings
http://www.ipharminc.com/financials
Patience: the capacity to accept or tolerate delay, trouble, or suffering without getting angry or upset
By choosing Group 2, I am displaying Patience
Hypocrite: anyone in Group 1 telling people in Group 2 to be patient
because all the results to date are hidden under a shroud of secrecy
i hope there is at least one pre-print coming out that will disclose the behind the scene players of in vitro testing to date
vaxart recently got nailed for fibbing about ows. not saying that is taking place here, but until the players are disclosed, credibility is hard to come by.
i do believe there are some posters here might actually have a more direct line of communication with him.
IPIX should name the CDMO by now
IPIX has done it in the past if they really signed a CDMO
July 2018
http://www.ipharminc.com/press-release/2018/7/17/innovation-pharmaceuticals-signs-drug-product-manufacturing-contract-with-corerx-to-formulate-and-package-brilacidin-for-oral-mucositis-in-sachet-form?rq=cdmo
April 2018
http://www.ipharminc.com/press-release/2018/4/23/innovation-pharmaceuticals-signs-drug-supply-contract-with-evonik-to-bulk-produce-commercial-grade-brilacidin?rq=cdmo
yes - you seem to have a good grasp of ipix and what need be done vs reminding the lemmings what has not unfolded. again, i appreciate the new story telling technique
Anyone who actually gets to communicate with Leo, do you think he would post/upload the FDA response that we were granted a meeting on the ipix website (update section)? Other companies would have included it in their 8K filing that went along with the pr. it is a material event.
the question should be 'has innovation pharmaceuticals meeting date been set according to their Oct 2nd Press release?" Supposedly this was done in writing.
i am usually the king of beating a dead horse and have people avoid me, but i am passing my 1st place trophy to you
there is a circular conversation on this message board and your creative ways of reminding the longs (or cheerleaders) they have been wrong is duly noted.
would a proactive discussion of what need to be done vs rubbing ipix's face in it's own feces on a daily basis be more constructive?
I assume hiring the clinical trial manager is in lieu of outsourcing to a cro. based on her linkedin employment history, seems like she does short term employment at various companies for trials
Previously ipix announced the cdmo when contracted - that would help reassure myself that the ind is moving full steam ahead. i assume the cdmo had to be listed in the pre ind package; the cdmo has to meet certain requirements
what scares me is that now seems like a 'no brainer' to buy when a pretty significant IND/FDA update is around the corner. Usually when i get this feeling is when the stock makes a small pop and then tanks. Maybe I am just getting immune to how long this is taking and now seems like a no brainer time to buy just like it did back in June?
https://clinicaltrials.gov/