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Looks like the PR might coincide with a 100/200 SMA cross.
BP and institutions waiting for results? Boy, this August sure is going to cause one hell of a ruckus.
Thanks for the link.
When it comes to explaining the science there really isn't anyone better than Dr. Alkon, but I also think it's perfectly fine for the CEO to focus more on the business side of things.
Most investors don't really care about the science anyways. They just want to know if they can make money off this or not.
Definitely something strange going on. The stock price has moved up in an almost perfect diagonal line for 6 days in a row now.
5 year study actually:
https://clinicaltrials.gov/ct2/show/NCT00002908
But yes, there's plenty of studies that prove myalgia is the worst side effect of them all, and that it can be fixed by simply reducing the dosage to levels that are way above what's being given to patients in the current trial anyways.
Here's another one:
https://www.ncbi.nlm.nih.gov/pubmed/9440723
"Total cumulative doses of bryostatin 1 up to 1,134 microg/m2 have been administered without untoward toxicity."
And this was in a study where patients were given a 9x larger dose than what's being used in the current trial.
It would take more than 28 months to get up to that level using our current dosing regimen.
Here's an article on long-term safety in cancer patients:
https://www.ncbi.nlm.nih.gov/pubmed/10931461
"Bryostatin-1 (25 microg/m(2)) was given in the PET (polyethyleneglycol, ethanol, and Tween 80) formulation as a 30-minute intravenous infusion on Days 1, 8, and 15 of each 28-day cycle."
"The treatment was generally well tolerated. Myalgia was the most common adverse event. One patient died while on study. This was a sudden death for a patient receiving a 15th cycle of therapy. Aside from this patient (for whom the correlation of study drug to death was not clear), no Grade 4 nonhematologic toxicity was encountered in more than 150 treatment courses delivered."
And this was with a 3x25mcg/m2 monthly dose. Neurotrope uses a monthly dose of 2x20mcg/m2, which is 47% less.
Now let's get a bit crazy and look at a study where they tried a 2x120mcg/m2 monthly dose, a dose that is 6x larger than what Neurotrope uses:
http://clincancerres.aacrjournals.org/content/6/3/825
"Our Phase I clinical evaluation of bryostatin 1 in patients with relapsed NHL and CLL defined the maximum tolerated dose of bryostatin 1, when administered over 72 h every 2 weeks, to be 120µg/m2 (40 µg/m2/day for 3 days; Ref. 10 ). Generalized myalgia was the dose-limiting toxicity."
"In general, bryostatin 1 was well tolerated. Six patients experienced grade 3 myalgias (severe pain with either pain or analgesics interfering with daily activities) requiring dose reductions. As in previous studies, myalgias became increasingly severe, prolonged, and generalized with increase in cumulative dose (median, seven cycles administered prior to development of grade 3 myalgias; range, four to fifteen cycles) but could be controlled by dose reductions and/or dose delays. Eight patients experienced grade 2 fatigue, and two patients experienced grade 2 infectious complications (one catheter-related and one cellulitis). There was no significant hematological toxicity."
As you can see, the most severe side effect this drug has is non-life-threatening muscle pain affecting 24% of patients, and that's after a median 7 consecutive months of taking a 6x larger dose, and even then the pain can be controlled by simply reducing the dosage.
Have you read the papers?
It explains in full detail exactly how it works and there's several patients with improved cognitive abilities to back that up.
This isn't "magic" or a "miracle". Just read the papers and you'll see exactly why these patients are improving.
Alzheimer's is a neurological disease so I'm not sure why you bring up physical health. Bryostatin isn't meant to help patients fix their cranky knees.
$315 billion/year will be spent on 8.4 million Americans suffering from AD in 2030 if nothing is done about it.
Giving all of them $10k/year bryo would cost $84 billion/year.
In that case the government would save $231 billion/year, which is a 73% cost reduction.
And that's without taking into account unpaid caregiving and wages that are lost by family members having to take time off work to care for their relatives suffering from AD, not to mention the emotional distress from having to watch them slowly turn into a shell of their former selves.
Restoring AD patients back to normal won't get rid of the nursing home costs?
I'm not sure I understand your logic.
"In 2019, Medicare and Medicaid will spend an estimated $195 billion caring for those with Alzheimer’s and other dementias—67 percent of total costs."
http://act.alz.org/site/DocServer/2012_Costs_Fact_Sheet_version_2.pdf?docID=7161
I think everyone will be happy with a $10k drug if it means not having to spend $25k on nursing homes and drugs that barely slow the decline.
I'm sure the government won't mind saving $117 billion/year either. That's more than $350/year for every American.
Expensive drugs means more revenue.
The government saves money by keeping patients out of nursing homes and hospitals.
The company earns more money which it can use to launch more trials.
Shareholder value goes up because revenues go up.
It's a win win win situation.
Either way, they'll pay much less for patients to munch on some bryostatin pills than what they're currently paying.
The current average annual per person Medicare spending for AD patients is $24,598.
$10,000/year Bryostatin pills would save the government several tens of billions of dollars every year, probably even hundreds of billions if you count people with other neurodegenerative diseases.
The extra money could also finance more clinical trials to get the drug approved for other indications as quickly as possible.
Insurance companies will be the ones paying for these treatments anyways, so I don't see why they couldn't make it more expensive.
I'm sure they'll accept paying $10,000 for their customers if it means not having to pay the astronomical amounts they're already paying for nursing homes and hospital stays.
If JPMorgan analysts can talk about $20 billion peak sales figures from Biogen slowing the decline, I don't see why they couldn't make a similar conclusion here for a drug that reverses the decline.
https://www.businessinsider.com/biogens-alzheimers-drug-could-be-worth-20-billion-2016-9
$8000/patient from 2 million patients would bring in $16 billion/year.
Based on this:
"Our convergent synthesis proceeds in 29 steps, with a longest linear sequence (LLS) of 19 steps and 4.8% overall yield (>80% average yield per step), and has collectively produced >2 g of bryostatin 1. All steps, except the final step for safety reasons, were conducted on a gram to multigram scale. This synthesis can thus readily supply the amount of material needed to further advance clinical evaluation, as a single gram of bryostatin 1 can treat ~1000 cancer patients (9, 11) or ~2000 Alzheimer’s patients (4) according to currently used clinical dosing."
https://science.sciencemag.org/content/358/6360/218
Even if they make 3g every business day that's still not going to be enough for the millions of patients suffering from AD, and that's without taking into account the bryo that Dr. Wender will need for his cancer and HIV trials.
Keep in mind that I'm not saying the limited supply will be limited forever. All I'm saying is that these things take time to really get going. Production always starts small and then grows bigger.
It's not so much about the cost than it is about the time it takes to manufacture it, considering it takes 29 steps.
2 million patients takes 1000g of bryo per year while Dr. Wender is talking about 2g in his paper.
I'm certain they will manage to get up to that amount eventually, but in the beginning there will be supply issues for sure.
Keep in mind that the drug price can be set reasonably high since there's too much demand for the little amount of supply we have.
The Janney report uses a yearly cost of around $8000/patient, which I think is cheap considering the limited supply we have.
For comparison, Namenda is $3600 a year and much much easier to manufacture.
Yeah, 10x revenue is way too high.
Valuations are usually based on expected profits multiplied by a P/E ratio around 15-25.
Here's one way to quickly come up with a valuation:
1. Make up a number for the following:
- The average amount of patients per year (a)
- How much each patient will pay for the drug per year (b)
- What percentage of that you expect to keep as a net profit (c)
- What year you expect the drug to be approved (d)
2. Throw your numbers into the following formula:
a * b * c * (2037 - d)
And there you go.
2037 is when Dr. Wender's patent for synthetic bryostatin expires, so after that there will probably be generic versions out that will eat into their profits.
Dropout rate doesn't change the required delta by much tbh.
With no dropouts there still needs to be a delta above 4.0, as you mentioned.
No, that would make the study underpowered. With a 20% dropout rate and everything else being equal, bryo patients will need to improve at least 3.3 points over baseline.
Placebo has to be at least 4.4 points lower.
I took another look at it and apparently it's 100 patients that are being dosed in this trial.
The last one had 29 (16+13) non-memantine patients on either optimal dose bryo or placebo.
Anyways, here's what I use to quickly figure out p values: http://www.statskingdom.com/150MeanT2uneq.html
They have to use 20% or else their price target will just look ridiculous.
Also, the 98.8% is only meant to be used for the previous trial, not the current one.
If they replicate results with 108 patients it will be more like 99.9%.
There won't be an extension.
If they can achieve statistical significance at week 13 with 29 patients I think it won't be too hard to do the same with 108 patients.
In fact, if you crunch the numbers you'll find out that repeating the last trial with 108 patients and a 33% dropout rate will still get you a p value below 0.001.
The last trial had a dropout rate below 20%, and that was with patients on memantine included.
They want to finish the current trial first before starting any new ones.
Here's a list of all patents granted so far: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=0&p=1&f=S&l=50&Query=IN%2FAlkon-Daniel-L.&d=PTXT
The 27 most recent ones are still in force, with the most recent one expiring in 2035.
Patients are dosed and monitored for up to 107 days according to protocol and the PR for enrolling the last patient was released March 13.
Add 107 days to that and you get June 28, which is next Friday.
It took them 2 months to release the data last time and if the same happens here we're looking at a top-line data announcement in late August.
Should be out next week I think.
I've been following this company for years and I'm still blown away by how ridiculous this is.
A drug that repairs brain damage? Valued at less than $80 million? Get out of here lol.
Yep, don't expect anything new until August.
It's funny how analysts have to use ridiculous discount rates and success probabilities just to get their targets down to a price that looks reasonable, and even then they're talking about a 100% price increase.
Everyone is being conservative because anything else just looks like someone repeatedly bashed their head into a calculator to get those numbers.
Alright, if we say it's 20% then the valuations would look more like this:
145,000 patients = $4.8 billion
1 million patients = $33.4 billion
3 million patients = $100.3 billion
At least their margin calls would help drive the price up even further lol
If you want to go by the Janney report you're looking at yearly revenues of $1.2 billion from 145,000 patients by 2032.
If 10% of that is profits, you can expect a $2.4 billion valuation.
If we increase the patient population to 1 million, we're looking at a $16.7 billion valuation.
3 million patients? $50.1 billion.
Nobody knows. Any post-trial valuation will be purely based on future expectations since they're not making any money yet.
If Biogen is anything to go by, it could hit $20 billion, but it could also go to $200 million.
It all depends on what investors are willing to buy and sell shares for.
Lol. Anyone selling naked calls is going to get their pants pulled down if results turn out as expected.
Selling $10 July puts? That's pretty bold considering results aren't out until August. The price could go anywhere before then.