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So let's pretend you are BARDA, you are tasked with protecting the US from biological threats. You come across Brilacidin. You have home run results during a pandemic and you show to your superiors. Do you think they conclude, "sorry we only committed to two different cell arrays, we are done here" or do you think they say, "wow, let's continue to test". Now 5 different cell arrays with home run results. Do you think they say " sorry we only committed to 5 different cell arrays, we are done here" or do you think they say "wow, let's continue to test".
More tests and more results and more tests and more results. You can bet something sure is cooking.
I think partnering is the prudent thing to do and do it now. Just like large quantities of vaccines that are made in advance completed trials, large scale manufacturing of B should be taking place in advance of completed trials. Having a large pharma partner will legitimize B and give confidence that manufacturing, distribution and post-approval testing will be fully funded. Gilead's R has just been approved for treatment. Gilead partnering with IPIX to secure B for COVID will enhance their revenue stream for R and possibly position them for many more indications that B will help against.
Notice how since Leo's email regarding the R&B combo results, the only other PR from him was the material event of a the pre-ind meeting request. We know so much more has happened in the past 4-6 weeks and we aren't hearing anything. That is the only conclusion that makes sense to me.
IPIX deal is soon and will be much bigger...
9/14 10-K: "Partnering opportunities with industry and academic partners are ongoing regarding COVID-19."
Excellent summary. Thank you.
Did everyone miss this part of the PR?...
Best of luck for a quick recovery!
Two thoughts to support this:
1) Get all the latest K information out public for negotiations. Intended to maximize value of K.
2) Partnering company may not have had interest in anti-fungals - therefore, Leo made the deal to give them an alternate life, rather than being abandoned.
In the end Leo's tenacity will prevail. His public role always leaves him at a disadvantage to the cowardice of anonymity. If I have to chose between the words of a public figure and anonymity, I chose Leo every single time.
I think you missed my point, but to each their own.
Please continue to mix "science" with "accounting" to your own ends.
It is my opinion, that this is not necessarily a lack of product just for a trial. I believe that government may be involved; requiring and securing the entire production process is the US with oversight for mass production. What will take a bit of time is mass-producing IV B for a market larger than just the trial.
Step one, figure out the dose.
Step two, build a secure, US only production infrastructure
Step three, start mass producing and stockpile several hundred thousand doses (with grant money)
Step four, announce a breakthrough drug
Step five authorize Emergency Use and run a controlled trial simultaneously.
Pure gold! Bravo
Most excellent news! Thanks for posting
I’m surprised our resident nit-picker didn’t find this. I mean after all that free “ helpful” information we get starting at 6 am on a Sunday morning until late evening. I’ve got my popcorn ready for the negative spin.
I am very much of the opinion that it is in IPIX's best interest to have a partner for this rollout.
I would venture that Leo also was saying Remdesivir is about to become obsolete. So if they want hold on to some of the COVID revenue stream, it is in their best interest to combo with us, because in the end, Leo has no obligation to keep a second-rate therapeutic alive.
Sorry, the link isn't to be shared with those that don't meet the criteria.
Post of the day!
You bet. Unless one is short-sighted ??
Post of the day!
Post of the day!
Fascinating! Thanks for this.
Thanks for finding this. Looks like we might be up for another PR Monday morning. With all of this ramping up by AVXL, gotta think they expect some good catalyst soon. Hmmmm....wonder what on deck next
How does it feel to lose to Leo?
Wow, Leo won? How does it feel?
Question: When Missling had previously been questioned about early approval etc., he replied it depends on the strength of the signal and the quality of the data (paraphrase from TTTav6 post)...Could the over-enrollment to the Rett trial be tied to this response? Maybe after the early look at the first 3 patients from the Rett trial, they could now estimate the "strength of the signal and the quality of the data", then use that to calculate a new n that would be needed for a particularly desired outcome. Any thoughts?
I also note that the study start date is October 7. Interesting.
I like 90% and 95% more than 100%.
With 100%, there is room for this number to potentially be misleading...like, what if only one or two patients were eligible for extension for some reason...well, 1 out of 1 is technically 100%
But,
90% has to be 9/10 or 18/20 or 27/30, etc. That's exciting.
And then for 95%, that's:
19/20 or 38/40. Simply... WOW
Some more deductive reasoning...
"Enrollment for the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study[4] is expected to be completed by the end of December 2019"
And since we know from clinical trials - "The study includes a 2 week Screening / Baseline Observation Period" ...
I have to conclude the only way Missling can say we will have completed PDD enrollment before year end is...
The final patients are already in the 2 week screening period.
Some deductive reasoning...
"To offer all participants access to ANAVEX®2-73 (blarcamesine) after completion of the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome study[1] and the AVATAR Rett syndrome study[2], 12-week and 48-week open-label extension studies, respectively were initiated. Currently 90% and 100% of eligible participants have continued into the corresponding extension studies."
So for US trial we have 90% requesting extensions. That is either 9 out of 10 or 18 out of 20. No other possibilities. Since I know that 6 were enrolled in Part A, I'm going to guess they were able to recruit more than 4 patients in part B. So I'm going to conclude 20 patients have enrolled. So someone help me with my math...
total expected Rett patients in US = 21. If 20 patients have been enrolled, how many are left before this reaches full enrollment?
Regarding Rett pediatric... This trial is not dependent upon finishing the adult phase 2 trials. I thought that was interesting and significant.
Highest enrollment in Australia ever for an Alzheimer's trial.
Something interesting I heard...
Alzheimer's enrollment is now expanding internationally.
CTAD Poster
poster
ARIA-H, microhemorrhage (%) 38 (6.9) 88 (16.2) 102 (18.6) 31 (5.7) 85 (15.5) 98 (17.6)
Human data, page 49:
BIIB presentation
Can you link this failed science? Tia
https://clinicaltrials.gov/ct2/history/NCT02756858?A=1&B=3&C=merged#StudyPageTop
click the link and scroll down. 2018 dates were changed to 2020. (I personally think they updated the wrong version, which is why it is somewhat confusing, but nevertheless, it was recently updated to 2020).
Hoping for some commentary on....
Well, the other week, we received a post that had an update from AVXLs PR firm (see post#218596). That update included...
It was pointed out the the 2b/3 for Alz has an updated timeline. Next I noticed a change in the Alz 2a extension trial. That is 4 updates on the same date. This is getting me thinking... anyone else have thoughts for why all at the same time?