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Bingo Billy. 3 in 1. 120 patients will be tested in the next weeks to come.
I would not be surprised to see several dollars
After reviewing several Remdesivir journals.... it really has an insignificant result. Maybe a day to two less care.
It will be interesting what IPIX and the FDA want to see in a 120 patients.
Discussion: What do you all think of 120 patient anchored with placebo?
I feel like for a phase 2, that is extremely light. So what 1/3 get one dose a 1/3 get a higher dose and a 1/3 get placebo.
I wonder what type of patient will qualify. And when they receive B
This is going to be interesting.
I truly believe this will be the quickest trial to date. So what is next? Final protocol and IND submission? Then a 30 day wait?
It’s unfortunate IPIX has to play this game as the straight shooter and go through the extra steps with no political backing by the big pharm, but Leo is going by the book and yes it has taken months longer to receive very promising data by 3 rd party labs but we have it and now should show the world just how powerful B is in a small trial. Over 100k cases a day - we can recruit 120 hospital patients easily.
Normally LEO would want to wait for end of phase 2 and suitor would want to wait. For confirmation and Leo would get a better offer. HOWEVER IMO this is Covid times and the waiting may just leave a partner in the dust.
Let’s say B shows the same results in the clinic as in the lab. Brilacidin will get that EAU and NOW......al of a sudden all of these other billion dollar opportunities like OM, Absssi and IBD indications become that much more valuable because Brilacidin will be on the market and being used already. IMO.
We are at a very important phase in this company history and Covid will have catapulted us way ahead in terms of value.
BP will have to step up now instead of trying to bankrupt us. Tides will rapidly change here IMO.
Gilead would be foolish to not open discussion on license agreement for combo. I think the just announced 800 million plus Revs from Remdesivir.
If this combo is accurate as to pre clinical results...this could potentially be a blockbuster combo.
IMO.
Or another BP could see the potential and jump in front to block Gilead from this move to own half of cocktail. That would be smart move.
Anyone read the pre print? I will in a bout an hour
All paper towels are already out of stock.
I honestly believe this trial can recruit 120 patients in a few week timeframe. Just make one of your hospitals in Wisconsin and you probably can recruit in a weekend.
The dark winter is coming and the surge is just going to explode. 120 patients is drop in a bucket. IMO.
They just submitted a new one for Covid and virus I believe.
I hope you are right. It’s about time for major developments.
I’m sure you read the guidance for Covid:
III. PRE-IND PROCESS
During the current public health emergency, with the large number of potential therapeutics for COVID-19 related illness, it is essential that the review process for investigational drugs be as efficient as possible. To facilitate this, we are urging sponsors to submit a pre-IND meeting request that allows early and thorough review and discussion between the sponsor and FDA, which can lead to more rapid review of the subsequent IND and assurance of subject safety, which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase. Given the range in clinical manifestations of COVID-19 and the large number of drugs and mechanisms of action being evaluated for use in this disease, the Center for Drug Evaluation and Research (CDER) has established a multispecialty, multidisciplinary team focused on review of drug development proposals.
We recommend that sponsors seek initial advice under pre-IND meeting requests.5 For the purposes of our response to the COVID-19 public health emergency, we are consolidating the typical pre-IND meeting request and package development process into a single step. For pre- IND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings, which FDA has described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).
Etc.... if done right and quality data is given the turn around time will be much quicker than a normal pre-ind and ind process. I would not relate to previous trials. This is Covid.
Thanks for all the well wishes!!!! Now let’s move forward IPIX and get into the clinic!
I’m hoping for news this week.
13 days battling Covid and I finally (knock on wood) feel like I have life back. I’d take the flu for 30 days over what I just went through. I pray for Brilacidin and other therapeutics to get to the finish line sooner than later. I’m only in my 40’s and it was brutal.
Cheers to everyone. I definitely have a FRESH outlook on life.
Go LEO!
I bet it starts in next few weeks. And trial s over in under 2 months. 120 patients can be done in a weekend. IMO.
Month 1 of quarter 4. Still a lot of time.
I think finalized data from RBL is what we wait on. Jmo
Great Article. In summary it hit major points of IPIX
Amen! So true.
So we would see Form4/
And know when that happens
Hopefully he raised the funds so when FDA IND is approved and we get go ahead....he does not tap Aspire during those very exciting months. That should spur huge Green Day’s
I’ll have to read the K. Have not had time yet. I heard here that UC trial will be in 2021 for Oral Brilacidin. Exciting times ahead. We just need to be patient and expect dilution for a bit until or if a partner or gov funds us. No one can hide the science so that is a positive.
Thanks for PM. Interesting info and I appreciate the info. I’ll keep it close to the vest and hope you are right.
Leo is doing what is needed. Imo
When supplying the packet to the FDA for a trial I think the company has to show where they can financially shoulder the trial. I THINK! So maybe they did all this because they are supplying the info
Well said. Covid May be around forever. It’s not going away anytime sooon for sure. Let science play out and hopefully B is a player and this all brings great PR. The pipeline is robust
IPIX is thorough. The long wait for pre-clinical data should hopefully propel the company into expedited trials for Covid. The super positive fact is that now Brilacidin is now adding viral indicationS to its arsenal. Plus the fact antibiotic resistance is gaining steam helps.
All pluses
These govt trials will set the stage
I honestly wonder if Leo has any say. This is a government lab funded by the government for these trials if I’m not mistaken. All IPIX had to do was supply them with B and their scientists did the testing in their fashion.
Unless it was GMU
It was great news. It may grab attention from Gilead but I believe Brilacidin is going to be great on its own.
Holy Crap!!! I know the company mentioned possible combo testing at RBL but honestly I wasn’t hanging my hat on it.
good morning gilead!!!!!
I’m giving advice to our CEO. Not talking to you Bond.
I think like Mo that these next 2 months are going to be fantastic for shareholders. Hoping a squeeze happens. Atleast for those 3 million real shorts. ;)
$20 squeeze Leo. Love your passion.
Great informative post. Excellent.
Ipix has historically always provided very detailed info to the FDA. They really cross the Ts and dot the i’s. I expect nothing less for this trial. I’d expect degrado to be involved
Better News- Kevetrin has more good data and published recently. Mid August.
What do the top 3 oncology drugs make? I can’t remember how many 10s of billions.
Good news. It will keep people in their toes......you never know when that FDA IND PR hits the wires.
Foundation is set for a speedy and fingers crossed successful clinical trial.
Let’s go!!! Early September starts tomorrow.
So do I! But how fun would that be for a quick simple buyout of 3 billion. That would personally make me multimillionaire in a blink. Lol.
Steady Leo. Get social and do an interview with some tough questions.
But.....if phase 2 kicks butt and we get an unbelievable readout on data....maybe 36billion MC hits like some of the other overflated Covid stocks. Lol.
Be well! There is a virus
Easy buyout at 3.2 billion takes that tough decision off our hands. A simple $9 share price is my low end. ;)