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anderson, yes customs could be a big issue. I have shipped many non-radioactive items overseas, customs holdups run from a few days to two weeks, in my experience.
I wonder if there is some customs priority procedure (e.g. medical needs like organs) that might apply to this situation, that would give a quick pass through customs? Do you know?
Having customers in Eu would not be without other issues. For instance, the half life is so short(2.7days), a day lost in shipping with no customs issues, would have to be accounted for. As long as the time is not excessive, it can be accounted for.
If an Eu supplier is needed, that will take time to set up, but that might be the long range plan...if there is an Eu plan at all at this time! LOL. I wonder how far along Dr.Korenko has gone with this thinking.
Dr.Olivier Keravel specializes in radiotherapy and veterinary oncology. He is not only a good veterinarian and leader in the oncology field, but he is also a good businessman! He started the first private veterinary imaging center in France. In 2014 he started the first vet oncology center, EiffelVet (www.eiffelvet.fr) in Paris. Dr.Keravel also authored the first vet book on animal CT scanning.
I just watched a video featuring Dr.Keravel titled "Expand Oncology in your Vet Practice with Orthovoltage Radiation Therapy". I dont know what the original intent of the video was, but it seemed to be essentially him promoting the Xstral radiotherapy equipment he uses. (XStrahl Model 300 I believe)
I hope we can get him on board as our Eu customer. IF our dealings with him go well, maybe he would be interested in being our 'point man' for getting other Eu clinics on board. I would like to see Isopet in Europe, be a cash cow for the business. That means a dependable/steady stream of income for the business, that could help fund trials.
Thanks for the info Cameron.
Dr.Kgoofing off for the summer talk is laughable! One man army growing isopet and moving fda progress along is a GREAT hardworking CEO. Longs better hope he never gets sick, or quits, or...
Does it fit the facts? I don't think DrM is trying to fry shorts at all! No ceo worries about such things.
I do think drM plays cards close to vest.
Steady, Definitely need more AD data. It is looking like AD and PDD are fairly well correlated, in terms of dementia, as emphasized by the last poster. And a2-73 performs as well as PD SOC Lepadova for the motor tests (generally UPDRS), and maybe better, maybe a lot better over time! Need longer testing, which I am sure the next PD trial will have. But for the memory/cog PDDementia, which is more like alz, a2-73 made amazing improvements in memory. Lots of good data for a2-73 from the PD/PDD trial.
These factors, along with Dr.M's comment about WT S1R and nonWT high dosing equalisation, give more reasons to expect good alz results!
That is good news. I noted that also. That gives us some idea of what is going on in the ALZ and PDD OLE. I dont remember Dr.M saying that before. Now not just the 85% WT patients, but all may be great responders
Georgejj regularly posts older news/leaks for newbies. Look at some of his posts.See australia news and caregiver comments. Much to some OTs consternation.LOL
The poster shows increasing correlation between ALz and Pd, in particular between patients treated with A2-73. That is good for Anavex as the good PD/PDD data points to good results for the ALz trial.
In terms of the 'another trial needed', that keeps coming up here, but I thought I read an article saying that is not true. Also, it does not make sense to design a trial, with FDA input and acceptance, then with positive results, the FDA says OK very good but we dont believe it, do it again, then maybe we will believe it...or maybe you will have to run it again and again... !!?? Does not make sense.
I dont share your pessimism. All trials have had good outcomes. Some, rightly say, there were only 2 super responders in the original ALz trial, but one must understand the 'binning' or subgrouping of the data there, to understand what percentage of the general population of Alz patients that represents. There are probably 100s of people that have now been through the Alz OLE trial, so Dr.M probably has all kinds of data refining the original Alz data. Time will tell.
I dblchecked it was 10.5k$, so 1 done in qtr.
I didnt check other rdgl twits, as I dont have an account. But I checked the last one posted here. It says 6:01A EST. Most medium sized companies have PRs (probably twits too) setup on timers to go out at a specific time. This size company, who knows.
Cam,the quarterly report listed only ~$6000 as revenue, so that means only 1 animal treated payment rcvd . Even that seems low, I thought they were charging 9K$.
Good to be checking that though! Would be nice to plot how those increase over they next year!!
Thanks Cameron.
Cameron, do you have a link to the web page showing the list of regional clinics?
I don't see it on radiogel.com
Thanks
Speaking of PRs. This is interesting:
Here are Anavex PRs for this year. Averaging 3+ per month, up until June with only 2, and July with NONE. Seems like the Anavex employees are busy doing ...other than press releases.
Jul 0
Jun 2
May 3
Apr 3
Mar 4
Feb 5
Jan 3
Whats interesting about the patent is that it gives lists of genes associated with neurodegenerative diseases that they suspect will be of interest. Because the Alz P2a trial was small, Anavex cannot conclusively rule in/out any genes on the lists.
However, you can bet they are KEMing the 509 patient's data in the P2/3 trial against these genes, and probably all trials going forward (at least CNS).
Yes, the S1R seems to be fantastic in its broad therapeutic value. It looks like the patent listed all possible applications of 2-73. There will be many trials run for years and years. It looks like Anavex is already moving 2-73 straight into P3 trials, so that will speed things up. As revenue rolls in, paying for many trials will not be an issue.
Once 2-73 is approved for sale, it will be interesting to how many people taking 2-73 for some problem, report improvements in unrelated health problems they have.
Hopefully, you get a 3 fer the price of one!
Wwweeee George, see page 6 of the patentapp!
You are gonna have to get a bigger chart
showing possible applications of S1R agonist A2-73. There are over 200 cancers listed!! I think they left a few out
Lots of trials to run for many years.
FYI:
JonJones, I think Dr.M has NOT committed to a completion PR. Nobody has posted a link showing where he gave any DETAILS of such a PR COMMITMENT.
As to what is going on, reread your post of the 17th when you correctly answered your own questions of then...and actually now. If the answer fits, maybe thats it!
Good luck.
George you are worth $180M to our marketcap. Dont leave like that again!!
Lol, good to have you back.
Doc, I think weeks/patient is not KEM analysis, but rather the time needed to do the genomic sequencing per patient. Takes time to build a persons full genome.
Yeah only about twice the volume of little Biogen.
Yes, the current cash balance is more than enough for trials for a while. But it also serves a secondary purpose, DrM can negotiate from a position of strength, that is he does not need any cash infusion or cash help.
He will probably get a nationwide pharma sales rep team to do the selling. They will certainly be selected after competitive bids are submitted. Similar quoting for the manufacturing, though he already has one he has dealt with in the past.
George, why would you think only 10% of patients would start taking 2-73? Probably 100% of patients in US are over 65yrs old so they get Medicare. Even if a few are not over 65 they probably are given Medicare or other insurance.
30fold, good question. I have thought about that for quite a while too. I think that would be a uncomfortable question for a CEO to have to answer, in front of a bunch of Rett parents, or Rett orgs, or congress. Go with they are priced the same!
(SteadyT, that is Occam again for the win!)
Jonjones, i liked your post of the 17th when you answered your questions of then, and actually now. Reread it and see if everything now fits with what you said then, regarding when we get the PR.
Umm. Yes it was a simple calc of SP of revenue, earnings and PE. Standard stuff for investors. Good stuff to know. Show your calcs then call it pie in the sky. Longs should know what they own, others don't need to care.
He has included the calculations in the past. Look it up. Or calculate it yourself.
Plexrec, is this holding up our PdPdd trials?
MJF Foundation article is trumpeting their support for the development of this imaging tracer (quote) "because of its potential to transform drug development."
And another similar quote from the article about developing Parkinsons drugs:
Bourbon, totally agree with your questions. Would add...
UPON Rett APPROVAL, is anything still needed to be done before sales, and what is the timeline to revenue?
I want to emphasize a shift from "a clinical stage biopharma" company to a profitable biopharma company!
blu1, He did not say what his source was. Maybe the Trofinetide P2? Or TLD?
DrMissling seems much more descriptive and 'GivemHell' since the JPMorgan meeting. I would love to know what his former FDA guys are telling him. He sure seems to be pounding Trofinetide lately!
Q/A notes from SVBLeerink CC
The QA session seemed to be the most interesting part of the call to me. Thought I would share this with the board. I think the host asked more questions than most hosts, and they were of good quality. I think some of the Qs came from the audience. Lots of interesting comments on Trofinetide. Also, the first question, I think, shows the line Dr.Missling must walk, trying to deal with multiple agencies, and resolve any agency issues to the satisfaction of the other agencies (that are not really involved in the trial)!
(These notes are not exact quotes, but should be the intent.)
Q. The FDA agreed ahead of time to the Avatar endpoint change, correct?
A. Let me use correct language, the Avatar study was done in UK and AUS, so these regulatory agencies approved the changes BEFORE the trial completed. The FDA was not involved in that study, just the US phase 2 study.
Q. Talk about the biomarkers that give you confidence.
A. Not only was S1, which is a biomarker of the drug changed significantly, correlating with the outcome. But also biomarkers of the disease, like seizures having low GABA and to high glutamate, and we were able to show that our drug reverses that. That is important because it addresses not only Rett syndrome, but also other diseases which we are going to address like FragileX. And when you look at LAAA, expressed in many degenerative diseases like Alzheimers and Parkinsons, we were able to reduce that. Thats important, because it shows that something biological is taking place that is beneficial to the system.
Q. And Gaba?
A. Yes Gaba deficiency is known to be associated with seizures, so we were able to show that increasing Gaba reduced the seizures.
Q. Thoughts on Trofinetide?
A. Looking at the Trofinetide study we were actually called from investigators and Rett family members, we were pointed out that just looking at the adverse event profile that there was high prevalence of vomitting(20%) and diahrea(80%). This is very inconvenient for girls that are bedridden or in wheelchairs. That is certainly a manifestation of the drug. We had none of that.
Q. Ref. the Rett program, when is the last time you talked with the FDA, and what is going to be needed to get that approved for Rett in US?
A. I repeat, we shared the US P2 data with the FDA, we need to write the Avatar clinical study report for the FDA but we are sharing this data with the FDA,
then we will discuss the next steps.
Q. That should happen soon?
A. Yes of course we want to move ahead.
Q. Comments on the ongoing trials in general and timelines.
A. Covid is having an effect on trials, but Alz is already fully enrolled, covid is only affecting Exellence.
I also want to point out we are happy to have two independent trials with improvements in Rett adults. Most trials target adolescents as they have better chance of responding. We are fortunate to have good results with patients up to 40 years old. This was not the case with Trofinetide, which didnt see any effect in adults. So it gives us extra confidence in the Excellence study.
Yes they are separate, and the OLE does not carry nearly as much weight with regulatory bodies, as you said, because it is typically not using a placebo and not blinded.
Highlights from Parkinsons Research Article - Dr.Simon Stott
I read Dr.Simon Stott's, rather long, but thorough article, "THE ROAD AHEAD: 2022". He broke down all of the research going on in the field of Parkinsons disease, with highlights of events to look for in 2022.
What stood out to me, was that he had the most praise for Anavex 2-73, with phrases like "This is rather jaw dropping stuff.". I was looking to see if he had kind words, like those, for any other treatment, but I did not see any. For others, I recall words like "very promising", and "looking forward to results". Dr.Stott's name should be added to our list with Dr.Hagerman et al.
The companies that seemed to have the best promise, were generally supported by MJF Foundation, or the "Cure Parkinsons Org", so kudos to them on supporting wisely. Simon openly pointed out the supported research.
Much of the research was in the preclinical, or phase1 stage, far fewer in Phase2, and even less in the Phase3 stage. This is to be expected, but what stood out to me was the depth and breadth of the research.
Also, of note were how failure was handled by a couple of companies (quoted):
jta1980,
you are on the right track. See posts 328230 and 342359 where I discussed this.
Growingpains, good find. TGD mentioned some time ago that he was trying to get Avatar and Excellence converted to P3 pivotal trials. This news was expected, but still good to see the change, as it means they have been in talks with fda, and got approval for the change.
I do not believe Avatar approval is linked to Excellence approval. There are several possible outcomes, most likely being Avatar approval for adults. After that there are the possible outcomes, one being just waiting for pediatric Excellence to complete, others are more speculative.
Yeah, I have complained about the lack of EXcellence sites being open, and the likely delay...while we sit on a pile of cash. AKA penny wise and pound foolish.
The only way I can see Excellence finishing up on M's schedule, is AVATAR good results/news, thereby motivating rapid enrollment into
Excellence. It does sound like there is already anticipation for the UK sites to get going.
Tidbit from JPM conference.
Dr.Missling gave maybe a couple nice tidbits.
He says he has the additional results of the PDD study. Also, and more importantly, he describes why the PDD trial data points to expectations of good results in the ALZ trial.
Here is the quote (my bolding):
hnbadger, holdup of pipeline updates explained
in this post.
I wrote this two months ago, and think it is still correct. The trials "undisclosed" and Angelman and FragileX are related to, and dependent upon the Rett Avatar results.
I suspect when the Avatar TLD PR comes out, there will be numerous communications soon afterwards, updating the other trial statuses.
So much potential against MS two years ago... with no further movement since, sad.
With cash flow, ALL of these opportunities should be pursued with MAX vigor!
Nice reminder traderpete.