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I 100% agree. This is certainly setting up for a run. Good luck to longs!
Good morning gentlemen. Decent volume yesterday. Plenty of covering taking place. Another green day on tap.
How many COVID drugs have been granted compassionate use by FDA BEFORE trial results are out...?
I can think of one. Are there any others?
Yes, the typical pattern continues.
Just wanted point out that Leo stated mid-to-late October. But....
if we go back and look at the last two times Leo gave us specific timelines...
He BEAT them. Handily.
Covering this morning. Clearly seen by the CDEL bid and ask sitting. Tick Tock.
Good morning gentlemen. October is here. We will be green today and for the foreseeable future.
Usually the algos that churn shares back and forth get switched off a couple days before a run up. I wouldn't be surprised if next week we get a massive move.
1). Interim safety review, check. Increase dose from 3 to 5 days.
2). 2nd interim safety review, check. No modification needed.
3). Compassionate use authorized by FDA, check.
4). ...?
Wonder if the first EUA will be Russia...?
"Elsewhere, Russia suffered its highest one-day death toll on Tuesday at 852, Reuters reported, exceeding the previous record set just last week. Daily cases started climbing in early September after millions of Russian students returned to schools and colleges."
B ordered for B-OM trial for Q1 2022. "We have ordered Brilacidin API (active pharmaceutical ingredient) for delivery in January 2022, for use in our planned oral mucositis Phase 3 clinical study."
Still have cash: "We currently have an approximate $11.3 million cash balance in the bank as of the date of this filing"
Here is our pathway to approval:
"Coronavirus Treatment Acceleration Program
FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The FDA website describes the program as one that “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” Subject to FDA approval, the Company plans to utilize this program."
Regarding grants..."Further, grant applications for federally-funded research are pending, and further grant applications are planned."
New info in the 10-K
"In July 2021, the independent DMC completed a second review of interim safety data from the Phase 2 clinical trial of Brilacidin in moderate-to-severe hospitalized patients with COVID-19. From their review, the DMC agreed to recommend the trial continue with no further modifications to the protocol."
I hope you all didn't miss this giant clue in our last PR:
I have to agree that the FDA ABSOLUTELY HAS TO KNOW the results in order to approve Compassionate Use. It makes NO SENSE for them to approve if Phase 2 results are just a few weeks away.
Remember then last patient follow up was July 30th.
Thank you DrBones! Boom!
This is good information to know! Thanks
Very interesting!
"In addition to Brilacidin’s antiviral profile, Brilacidin’s immunomodulatory and anti-inflammatory properties may be particularly beneficial in treating COVID-19 in hospitalized patients."
B's a three punch combination for COVID patients. BOOM!
Has the FDA gone mad! How could they they do this to the poor souls?!? I mean, the dying patients might get some temporary numbness in their toes!!!
Quick someone reach out to the FDA and let them know it is much better to let the patients die than risk tingly fingers!!!
Excellent observation. To me, it would seem much more normal for compassionate use requests and approvals to be made AFTER phase 2 (because they had results and therefore received requests).
This very much suggests that some data is already known for the FDA to grant compassionate use BEFORE publicly releasing top line results.
This is a huge read-between-the-lines.
Oh, good. You can host the first of many celebration parties.
We are ready Leo!
Yes, I noticed a change in behavior yesterday. first 30 minutes shows 30K shares traded. I don't recall a start of day with such low volume. Tick Tock.
We are ready for you Leo!
checked my TD ameritrade account.
More shares rolled over into long term capital gain territory.
I'm ready for you Leo.
CDEL just flinched and initiated its short-covering behavior. I will mark this as an bottom. Up from here
Last year's 10-K was provided on 9/14
Sorry I missed this! I’m sure Hugo’s would love to opine too! Beautifully said
Awesome, ROMAD! Designed for EUA!!!
This is my belief as well. Also note that Leo's timelines are all being met (actually all recent have been ahead of schedule). The US and Russian government (at a minimum) and at least one BP (likely up to 3) are ready for results. And Leo is getting everything finished as fast as humanly possible.
Absolutely believe there are high expectations from all parties mentioned above. Now all that's left is determining HOW robust the results are...
Is this thing about to explode up? Where's TD when you need him...?
Fantastic news! We could have results in August or Labor Day + 1 (which if I recall correctly was TD's prediction...?)
Don't forget the Nekkeds
Nice covering going on this morning. Today will end green.
Pick up phone
Dialing...
Voice: "Privet?"
Leo: "You good?"
Voice: "Da"
Leo: "Good."
hang up
Pick up phone
Dialing...
Voice: "Hello?"
Leo: "We good."
Voice: "Good."
hang up
Covering continues with CDEL bid and ask sitting.
Can you imagine...
When they find out that not only does B kill the virus in people and expedite our drug to market, but....
You can use is as a coating on surfaces such as door handles, utensils and other frequency touched surfaces, essentially shutting down surface to surface transmission...
$$$$$$$$$$
Data lock PR coming next week!