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Thank you for that list. It is interesting that Remdisivir is just 3 notches above.
Brilacidin was chosen to be one among the 1100+ drugs on which an AI algorithm was run. Isn't that remarkable in itself?
No matter how many rodeos you have been on, the chances are still probabilistic. IPIX did not start a trial based on a hunch. It was based on the results from the work done at 2 RBLs which showed a significant inhibition of the viren when treated with Brilacidin. So the probability leads more to a successful trial then the non-significant outcome you are suggesting. Moreover, this is not Brilacidin's first rodeo with a trial.
Could it be that the lack of enthusiasm for CERC's announcement stems from the fact that their candidate is a monoclonal antibody, and therefore harder to manufacture in bulk and is also more expensive?
https://www.nature.com/articles/d41586-020-02965-3
Moreover, they are up against Regeneron's candidate, and Regeneron is considered to be a leader in their Covid therapy.
Brilacidin falls in a different class of drugs, and does not have a direct competitor...yet.
IPIX is no longer a start-up. It's been on the biotech scene for more than a decade. Any "financier" would only offer a predatory lending for a biotech on an OTC with a stock price hovering in the low pennies. If our CEO was not also one of the largest shareholders, the company would have already been sold off for peanuts, giving himself/herself an out of the door bonus...the interest of a majority of shareholders be damned.
It is interesting how these doubts are raised when the stock starts going down after a faux rally in the price. Investors claiming a large stake in the company now say they have taken a little off the table sowing more doubt.
What has changed really? The trials which will make (or break) this company have just started. I consider that as a positive. We are in a good financial position per the latest 10Q, which I would also consider positive. A partner for UP just announced the end of P1 and the initial stages for a P2. Again a positive. P2 for UC through the oral route will start this year. Hmmm...that again sounds positive to me.
The runway for day traders is getting shorter and shorter by the week. Therefore, the desperation is palpable. After all this stock has been a lunch money cash cow for more than a decade, and the thought of losing it may be disconcerting to some. So one last slog to get a final pay-off before the great reset.
Significantly underestimated.
If we reach the EUA stage, the value would be much more than what you estimated.
We will receive a number of pre-orders, estimated as follows:
North America: 150,000
Europe: 150,000
Africa: 150,000
Asia, AUS, NZ: 150,000
--------
Total: 600,000
Net Earnings: 600,000 * 3000(net of cost, same as Remdesivir): 1800M
EPS: 1800M / 600M(Outstanding fully diluted): $3 per share
Estimated stock price: $3 EPS * 5(forward PE) = $15 per share
Market Cap(Fully diluted): $15 * 600M = 9000M ($9Billion)
Both the total sales and PE are very conservative. Considering the future value of Brilacidin, a PE of 20 would be more appropriate.
I am not sure if you read this, but here is a good article in NYT lamenting about Therapeutics.
https://www.nytimes.com/2021/01/30/health/covid-drugs-antivirals.html
Some notable points:
"In February, Dr. Chanda and his colleagues began a different kind of search for a Covid-19 antiviral. They screened a library of 13,000 drugs, mixing each drug with cells and coronaviruses to see if they stopped infections.". Do you know of a drug that went through a similar process?
"Experts are particularly eager to see this data because molnupiravir may be effective in treating more than just Covid-19. In April, scientists found that the drug could also treat mice infected with other coronaviruses that cause SARS and MERS.". Do you know of any other drug that could do just that?
My questions are rhetorical, of course. But you could feel that the spirit of the article was meant for Brilacidin and IPIX, yet there was no mention of either. It was so weird when I read this yesterday. I can't wait for our trial to start.
Or the army took a wrong turn and ended up in a ditch ;)
Well, the hastily raised finance concluded on 12/09. Considering where we are, it wouldn't be a stretch to posit that the raise was to compensate the CRO. This means that the CRO would not have done any work prepping for the trials till they saw the dollars.
Assuming it takes a quarter to prepare for the trials, that would take us into the end of February. And just to be safe with our timeline estimates, since this is IPIX, end of March would be more realistic. Another month and a half for all 120 to be dosed, that would take us into mid May. Then another month to collate the data, and we are seeing mid-June for the publishing of the results. So let's sit tight till then.
Nothing happens in a vacuum, every cause has an effect. Just dismissing the capital raise as a nothing burger was foolish.
Investors, like fish, chase the shiniest objects...the Teslas, AirBnBs of the world. A biotech on an OTC, with no revenue, and a stock price in mid-teens(pennies, no less) is not going to blip anyone's radar. That said, this is why investing in a biotech company is so rewarding, because if the candidate product succeeds, the return would be in the multiples, unlike just the doubling we see with DoorDashes and AirBnBs of the world.
We are almost there.
IPIX had 5M+ in the bank. They could have tapped that for their immediate need, and then gone with Aspire to shore up their finances.
Nothing about this transaction makes any sense, at least not at the moment anyway.
I like your optimism here, but I must admit the 8K dented my outlook towards this stock this morning. I have been bullish all along but not today, and tend to agree with Lemoncat's post here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160092746
I think we could have waited till the trial results to buoy our stock before going for another round of financing. This dilution will add, in the worst case, a quarter to our outstanding. I don't think this is a good place to be in. We have enough product for further trials, if need be, so why this rush?
Yes, your chart shows actuals from 2017. The chart I linked to are estimates based on actuals for 2020. The model is revised as more actual data becomes available, the last revision having taken place two months ago, on September 9th, 2020.
If you have other charts to refute this, I would be happy to see them.
Here is a more recent chart which contradicts your assertion.
https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm
To add to what you stated, the 3 panels tell a story. The first, an EM image of the virus envelope being compromised by a peptide. The second, a diagrammatic representation of this mechanism (the external source of this diagram being irrelevant). The third, the peptide (Brilacidin) responsible for this.
I don't see why, otherwise, would these panels appear on the same slide if they weren't telling a story.
"up to" as I understand is the upper bound for the approval/rejection. If the pre-IND concerns are adequately addressed in the IND, isn't it more likely the approval would come faster? We are having 180K infections a day. This is not the time for the FDA to smoke a cigar by the pool and look at the IND at their leisure.
Today's PR sets your Time-Table in motion.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159356887
Can't wait for the trial to start followed by the interim results.
Since we are going with a trial size of 120, is it required that the trial be done at different sites? If done at the same site the SOC should be uniform across the trial population. It would also be easier statistically to determine how many of the mild/moderate cases go on to be mechanically ventilated on the placebo arm vis-a-vis the treatment arm, wouldn't it?
I don't think measuring mortality would be one of the endpoints considering the small sample size and the mortality rate being approx. 1%. This will need to be determined during a larger P3. Just measuring the progression from mild/moderate to severe would be a good test in the P2 trial, since it will also provide a virtual peek on its impact on mortality.
After we get our trial results. Any response before this would be fleeting.
That's good to know. Thank you.
Will IPIX have to wait for the pre-print to be published before it makes the IND application...you know to improve the chances of its approval, or could we go ahead with the information we have?
My concern is the IND application being declined or delayed by the FDA for want of RBL's testing results.
I would appreciate if you could shed some light on this.
Farrell, you are the best!!! Thank you for taking the time to compose this wonderful summary.
Did anyone notice this sentence buried in the PR "In separate news, the Company will be submitting a briefing package shortly to the FDA in preparation for our planned clinical study of Brilacidin for COVID-19."?
For me, this was the bigger news.
Could it be that IPIX doesn't care to be on the OTC any more? In the sense that developments later this month will enable it to upgrade to a better exchange, NYSE or NASDAQ perhaps?
Just my muse.
We will get through this like we have since WWII. You may not have faith in our country but I do.
You are forgetting we had a crash in 2008. Were there no 2, 5 and 8 year olds then? What became of them? Did the economy never recover? Did the biggest economic expansion since 2008 with unemployment falling to 3.5% never happen?
Some leaving is hardly an exodus. And once realization dawns that the premier entertainment in their new place is dancing with goats, they will be drawn back to the hustle and bustle of a city. Despite all its challenges many still prefer to live in cities.
A business can always be rebuilt. A dead person cannot be brought back to life.
Well, our approach has been similar to Sweden's without intending it to be. You could hardly say the lockdown was total in the initial days, followed by re-openings by States earlier than advised (See FL & AZ), and then the "I refuse to wear a mask because it intrudes on my freedom" crowd.
Why not advocate for the opposite and give New Zealand as an example? With half of Sweden's population but only 22 deaths.
If, Brilacidin or a vaccine, becomes available tomorrow, which country do you think would have prevented needless deaths?
This debate is akin to those advocating for a war...cheer for one as long as I and my loved one don't have to go fight it. I will just sit on my couch and watch how it goes on my tv.
According to Worldometers, Sweden's tally is 575 deaths per million. Hardly a cause for celebration.
Nah, that's not it. It's when Mercury fondling Venus gets Jupiter into a rage that gets IPIX going. That would be 10/03, a Saturday. 10/05 is the earliest the market can open. You heard it here first.
What purpose will a little green serve? If you can see the big picture, pennies are not what we should be counting.
The decisions in the last 6 years were advised by the dough we had in the bank. So instead of doing just one phase 3 trial for ABSSI and exhausting all our resources , we went for multiple trials:
Phase 2a for Kevetrin
Phase 1 & 2 for OM
Phase 2 for Pruirisol
(I am leaving out the Oralogik trial)
I personally think that was a good move based on the funding constraints, but many on this board think otherwise.
But this time it is different. We have an health emergency with 170K+ dead...and counting, lackadaisical therapies in Remdesivir and others, with the efficacies of vaccines in trials still up in the air.
So if our first Covid trial succeeds (considering the excellent SI numbers we received today, I am confident we will) this stock will easily hit double digits. I would like to say triple considering that it would also be effective against other Coronoviruses, but why not be a little conservative. At this point this will be out of our hands because DoHHS will steamroll it to phase 3.
If the trial does not succeed, however, I fail to see how the stock will be priced higher than zero, because we would have exhausted all our resources by then. This will lead to a firesale of OM and other indications and at that point the company will cease to exist. There would also be no one on this board in a year's time.
But I would take the happy path because probabilistically our odds from today's numbers look very good. Payday is just a quarter away. The stock gyrations till that point are meaningless.
I was addressing the specific question you asked. I guess when you don't like the response, then duh could be the only logical reply left.
European travel was curtailed after the horse had already bolted. The prudent thing would have been to stop travel from all over.
Biden has no experience with the Ebola outbreak?
The first cases in NY were primarily from Europe. So there's that.
https://www.mountsinai.org/about/newsroom/2020/mount-sinai-study-finds-first-cases-of-covid-19-in-new-york-city-are-primarily-from-european-and-us-sources-pr
And I am sure you believe Earth is flat too!
Brilacidin has yet to start a Covid trial. If one was underway then there would been some substance in speculating that B might be a subject of the announcement. Unfortunately, we are not there yet. So I don't see how this could in any way be related to B.
We will know from the pre-print if Brilacidin works by neutralizing the lipid envelope of Covid-19. If this indeed turns out to be the case then it will also be effective against the flu which, being a coronavirus, shares the same lipid envelope. What this means is B can prevent another 100s of 1000s of deaths from the flu each year. If that's not a blockbuster drug, what is?
The IND application shouldn't take too long if FDA adheres to the CTAP program they announced a few months back:
https://www.fda.gov/media/136832/download
The manufacturing, however, is a big question mark. But I agree that any significant appreciation in the stock price could only be sustained after the successful completion of the trial. Absent that, any appreciation till that point would only be a fun ride for day traders.
We are excited too. But it doesn't take an astrologer to tell us that.
Astrologers speak in tongues.