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OMG! We should all go to the respective message boards and warn them of high side effects and low efficacy!!
I couldn't agree more (trademark pending, thanks TD!).
However, if we don't get any early leak, I anticipate after we cross the 1 month mark (or thereabouts), we have all kinds of possibilities such as full enrollment PR, interim results, and everything that follows from there.
Some anticipation will start to get priced in too. My guess is gradual run to $1 starting March 22. Interim results (DMC) recommending no changes adds $.50. Then full enrollment email gets us to $2.50
If followed by positive results... we open another 300% higher and end the day 500% higher.
Hmmm, maybe the presentation will be next month...?
"Russia is planning to present an "antidote" to Covid-19. It is expected to be more than 99% effective. This was stated by the head of the Federal Medical and Biological Agency Veronika Skvortsova, according to the website of the Russian government."
"The drug that I would like to talk about is the first etiotropic drug that directly affects the virus. In fact, it is an antidote to coronavirus infection," Veronika Skvortsova said.
"The effectiveness of this "antidote" in preclinical trials was up to 99%. If clinical trials are successful, it will be the world's first direct-acting antiviral drug."
antidote
And we should get more sites up and running to treat patients through next week
Agreed. Everything else is just FUD!
There are many dots that at one time, weren't clear. Now we are able to connect them. TICK TOCK
Didn't we poach a Sanofi clinical trial manager...?
Good morning and welcome to the future front line COVID-19 therapeutic.
I don't think it is a lack of comprehension, but a calculated means of trying to artificially minimize the impact. With such a long-winded and clearly inaccurate representation as that, I am led to the following conclusion...
They are clearly paying attention. They are clearly worried. They are clearly trying to distort. They are clearly going to pay.
T minus 19 days or so.
Tick tock.
Watch this video
I think IPIX will benefit from these legislative changes
It is nice to see another existential threat against them.
I couldn't agree more, JFM!
Wonder if the new rules regarding the short-selling merry-go-round are having an impact...
Is everyone else showing only 235K shares traded today...?
I'm glad to see it was another Moscow site added. Trial will enroll quickly in Russia because there are tons of new cases everyday...
https://www.statista.com/statistics/1102935/coronavirus-cases-by-region-in-russia/
AND...different from cancer or a disease with low incidence, these hospitals will already be stacked with possible patients and dozens coming in by the day. COVID doesn't take the weekends off, neither will the recruitment of patients.
We have 4 sites scheduled for recruitment in Moscow and 4 sites scheduled for recruitment in St. Petersburg. Currently 4 are recruiting with more sites to activate.
This trial is going to enroll in no time...
Russian COVID stats
Such an easy choice to enroll....
Would you like to enroll in a clinical trial where you will receive either:
Standard care...
Or
Standard care with promising treatment...?
"YES, PLEASE"
So let's work backwards...
Estimated primary completed date: June, 2021. Let's split the middle and assume June 15th.
Since the Primary completion date is: time to sustained recovery through Day 29 (let's just estimate about 30 days to make the math easier)...
June 15 -(minus) 30 days gets us to around May 15 for the last patient dosed.
BUT...
We know there is a DMC review which may modify treatment from 3 to 5 days, so...In my opinion, they would have to have that review and decision before April 15. My guess is that the interim analysis is concluded early April.
That's about 1 month. Place your bets.
When I got my shot through the phase 3 novavax trial...this happened in the immediate 5 minutes before my first shot. Once all the screening, review and documentation was signed, they determined I met the inclusion criteria. The next step was for them to randomize the injection so it would not be known if it was placebo or vaccine. It's not as complicated as some try to make it
Much appreciated. Thank you.
What is the market for B for COVID?
Well, let's say that the vaccines are very effective and let's assume there are no variants. If we start with 300 million US people and assume 95% are vaccinated and don't require treatment, leaving 15 million folks not vaccinated. Then of those 15 million, let's assume only 10% develop moderate to severe COVID. That's about 1.5 million folks. Now if we assume B to cost $2,000 per dose and it's a 3 dose regiment, that comes to $6,000 per treatment. $6,000 * 1.5 million equals 9 billion dollars.
$9B/400 million shares = $22.5 per share
Now...1) not everyone will vaccinate, 2) there are many variants and more variants to come, 3) B should work against other viruses, 4) other countries will order B, 4) B will be used for other indications like bacteria and as an anti-inflammatory...
Well, it kinda hard to put a price on the value here...
Some simple math...20 Russian sites and let's assume 10 US sites...
30 sites and if each site gets 1 patient per week, that would take 4 weeks to enroll. If the sites get 2 patients per week, well...we could already be fully enrolled.
Now since there is interim analysis, they are not going to wait until the trial is fully enrolled, otherwise, it would be too late to adjust anything and therefore, no point in interim analysis.
My guess is interim analysis is next week. If no change to protocol, I say...we are golden.
The modify date is a bit of a misnomer... if you look at other drugs, they also show the 2/27/21 date.
Think of it more as...this information is current as of 2/27, not that something with this particular drug changed...
I'm very excited to see that B is a three day regiment. If they use a low dose over 3 days, it will certainly minimize any side effect and give much more time for the drug to work. And if for any reason 3 days is insufficient, they can increase to 5. I really like that this trial can adapt. Also this puts a lot of focus on an interim review by the DMC.
So couple things. If Leo PR's us in the few weeks and says, the DMC has not recommended any changes to the protocol, then IMO we are GOLDEN.
Also, the 3 and 5 day dosing is FANTASTIC news from a business point of view. We will get a lot more revenue for 3 doses than 1. $$$$$
This trial with recruit quickly and ethically. Easy decision to enroll when treatments are either standard care or standard care + promising therapeutic.
My guess for the reason why "standard of care" with no specifics is: The standard of care is probably different in the US and Russia. Enrolled in trial through US sites?... receive US standard of care. Enrolled in Russian sites?...receive Russian standard of care.
I edited my reply.
Leo raised enough cash, so he doesn't have to tap Aspire during negotiations. Now that his options were converted and MFO money raised, the partnering company knows the final share count. Tick tock.
Hell, I'd take a dose of B if offered, even if I don't have COVID. Imagine all those other pesky viruses we have that we are unaware of...?
This looks ready to run...
develop - grow or cause to grow and become more mature, advanced, or elaborate.
Over 2700 following...growing...and Growing....and GROWING.
I almost feel sorry for them....almost...
You bet! I just searched the ipharminc website and can only still find reference to the pre-print, not the peer-reviewed document. Maybe Leo doesn't know about it (LOLOLOL).
Can I kindly order a case of tissues? If people cry this much about .05-.10 fluctuations, can you imagine the crying for .50 intra-day fluctuations?
Hmmmm....overseas approval....yet, no PR...hmmm....peer review published, but...hmmm...No PR? Hmmmm....trial might have started....but NO PR....
HMMMMMMM
Over 2500 following...growing...and Growing....and GROWING.
Winner, winner, chicken dinner!
BOOM! I almost feel sorry for them....almost
Sure seems like something is cooking