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Thanks coach.
If he's on record saying he can scale-up to 20 grams in 1 manufacturing batch, that's about 1 million doses per batch.
At ~25 doses per patient per year, 20 grams would treat 40,000 patients for a year.
To treat 400,000 patients per year, that looks like 10 manufacturing batches per year.
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If this was Walter White's lab, each batch could be done in a long weekend, as long as the precursor is readily available, lol.
Taxol (paclitaxel) is a chemotherapeutic drug with current annual sales of about $1.5B.
Taxol is used to treat many cancers--breast, ovarian, lung, bladder, prostate, melanoma, esophageal, and other solid tumor cancers.
Natural Taxol is also expensive because it's harvested from a rare plant (the Pacific yew).
Because it was so expensive to harvest, the drug owner sought a synthetic process to manufacture it (in the 1990s, I believe).
Sound familiar?
Full synthesis of Taxol requires 40 chemical steps.
Bryostatin synthesis requires 29 steps.
Have a look at Wender's bio (he holds the patent on the synthesis of Bryostatin). I'm sure runncoach can give us a bit more detail, but just based on what I've seen of his bio, my guess is the synthetic process is well beyond the whiteboard stage and large-scale manufacturing is probably ready to go. Dr. Alkon himself has said that the synthetic process won't be a problem.
Lol! Copyright available to anyone that wants to use it.
Yes! Finally getting some independent analysis from outside of the company.
Hopefully just the start of analyst reports before the results readout in Aug/Sep.
Exactly right.
Doc:
Thanks for the reply.
RE: co-primary. My concern was that statistical alpha would have to be split between the 2 co-primaries (.025 each), but I feel better that approval could happen with just meeting one.
Coach/antii also gave a good example (memantine) of getting approval with meeting just one secondary endpoint in their phase 3.
antti:
Thanks for link, and yes the CU patients play a big role in my confidence in what Bryostatin can do. Significant improvement in cognition AND in function.
Wender et al have been working on the development, chemical process, scale manufacturing and pre-clinicals for the synthetic for at least 24 months, so I believe that is close to completion, which is a prerequisite for using synthetic Bryostin in human testing.
Wender et al have been working almost 18 months on the manufacturing site. I would imagine they are getting fairly close on the cGMP certification of the manufacturing site by the FDA, which is one of the prerequisites for approval of Bryostatin.
All of this work will be formalized and included in the CMC section of the NDA, some sections of which will be written while in-human tests are concurrently running.
Biotechs do this drug development all the time. It's not like preparation for the approval process has never been done before by a small biotech.
And 100's of biotech companies have successfully done bioequivalency testing for synthetic formulations, so it's not like NTRP is breaking new ground there. Generics anyone?
And 100's of biotech companies have successfully done oral formulations from IV formulations, so it's not like NTRP is breaking new ground there.
You may have angst about their success, but shareholders seem to trust that these manageable steps will get done for a successful product, if the Aug/Sep trial results are successful.
Equivalency studies can be run in parallel with other studies.
Quite the story AXSM has. Thanks for giving the details.
Great choice as a comparison to what will happen to NTRP if our trial is successful.
Yeah, they each own an average of 2.5M-3M shares. lol
More likely, it's exactly as Whatsupp stated earlier:
"How can you say it is a hand full on Ihub poster with over 100 qualified investors that have been involved in private placements and 37 institutional owners of 27% of the stock."
https://fintel.io/so/us/ntrp
The appetite from outsiders could be a problem at this moment in time.
And it is very likely these outsiders are using fallacious arguments in their own logic, without looking at NTRP's data:
"99% of Alzheimer's trials have failed, so I'm not going to invest in any Alzheimer's companies"
* But, MDD trials had an extremely high failure rate, while AXSM succeeded and were rewarded handsomely
"If big pharma can't solve AD, how can a small company solve it?"
* From a fortune mag article: "Pint-size ventures are driving pharma innovation. The majority of drugs approved in recent years originated at smaller outfits—64% of them last year, according to HBM Partners, a health care investing firm."
"But look at that small market cap"
* Same could be said about every successful company at some point in their history.
Everyone has their own individual risk assessment of NTRP's chances of success in Aug/Sep.
And, I think everyone should follow their risk management plan.
For instance, you believe AVXL has a 30% chance success, while others think it's 100% chance of success. Would you change your plan because others think there is a 100% chance of success? That wouldn't be good risk management.
Agree red:
If results are successful in Aug/Sep, there will either be a bidding war to partner with NTRP, or a bidding war for buyout.
A market cap below $500M would be an outright steal after successful results. Between $500M-$1B would be good value.
Yes, and those who are "concerned" about the low market cap of $90M have already lost the opportunity of doubling their money when it was trading at a mere $45M market cap less than 6 months ago (~$3.50/share).
Oh well. As they say, you can lead a horse to water...
Yeah, AXSM at ~$75M market cap 6 months ago was "too good to be true".
Until it wasn't. Current market cap ~$750M (a 10-bagger).
Yeah, ARWR at ~120M market cap 22 months ago was "too good to be true".
Until it wasn't. Current market cap ~$2.6B (a 20-bagger).
So apparently market cap doesn't predict success. No kidding!! Your "but the market cap" argument has no basis in reality.
Warren Buffet doesn't agree with you either:
"Price is What You Pay; Value is What You Get"
Yeah, he's the master of paying full price for his investments, right?
I'm quite sure all drugs have side-effects; there's always a trade-off between the benefits and side-effects.
Certainly, surviving longer is a nice benefit, and most would be willing to put up with significant side-effects for that.
And as long as the side-effects are less severe than not taking the drug, then that's a good trade-off.
Insulin would fall into that category of a drug with relatively minor side-effects relative to the long-term damage caused by uncontrolled diabetes.
Possible long-term damage from uncontrolled diabetes includes: Cardiovascular disease, Nerve damage, Kidney damage, Eye damage, Foot damage, Skin conditions, Hearing impairment, Alzheimer's disease
In long-term trials, Bryostatin has been shown to be safe. Phase 2 results show it may be effective in reversing Alzheimer's. We'll know in Aug/Sep.
Coach:
Johns Hopkins Univ School of Med (where preclin work on Bryostatin in MS was done) is a premier research site:
"Johns Hopkins has consistently ranked among the top medical schools in the United States, [and] in the number of research grants awarded by the National Institutes of Health.
One of the quickest ways to lose NIH research funding is to falsify information.
The following statement was repeated a few times in the journal article:
"These findings suggest the potential for bryo-1 as a therapeutic agent in MS, particularly given its established clinical safety"
They know better than anyone that MS requires a lifetime of treatment in most patients. They have no concerns about long-term use of Bryostatin, based on their research of previous Bryostatin trials.
I'll take them at their word.
Definitely agree.
Doesn't matter to me whether Fragile X and MS trials launch after AD results or before.
None needed.
I trust the peer-reviewed article.
You don't.
Do your own investigation.
MS is a disease that requires long-term treatment, in many cases for the rest of your life.
So I trust that the authors (research experts in MS) and the peers who reviewed the article, know what their talking about when they say "The established clinical safety profile of bryostatin-1 in humans could expedite its development as a therapeutic agent in MS".
If you really want to follow the journal article references at the bottom of this peer-reviewed article to satisfy your curiosity, feel free.
I trust the article/authors/peer reviewers, so it's not necessary for me to check their work.
To each his/her own. I think most here know that a peer-reviewed journal article can be trusted.
More from that peer-reviewed paper on MS:
I'll trust a peer-reviewed paper over anything posted on a board:
https://www.scribd.com/document/386853846/Bryostatin-1-alleviates-experimental-multiple-sclerosis
Whatsupp:
That's a very good point...with the stratification you are referencing, we will see if both moderate-to-severe and severe AD improve equally. That will definitely give a good clue if Bryostatin has a good chance of working in mild and mild-to-moderate AD.
I'll leave to the readers here to make their own decision as to whether there was substantial improvement in quality of life in both Frank Carney and Jenni Spencer:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148337577
My opinion: yes, absolutely substantial improvement in both compassionate-use patients.
Post-hoc analysis isn't highly suspect when it's pre-specified, which it was when NTRP ran the trial.
The other potential CNS indications, even if they start in the next few months, won't have nearly the impact to NTRP value as the Aug/Sep AD results.
"Reversing Alzheimer's damage from level 10 to level 8" (NTRP) in a double-blind placebo-controlled trial would be unprecedented...never been done before.
"Reversing a 5 to a 3 and holding steady for years" in an open-label non-controlled trial is highly suspect.
This is why, if NTRP succeeds in their phase 2, I am convinced they will have financial success.
Or could it be, like AXSM, NTRP is a diamond in the rough, poised to go up many times your investment if the results are successful?
You never know—might be worth exploring in preclinicals. There are similar nerve cells in the spinal cord, so I guess anything is possible. Might be an adjunct to other modalities (surgery, stem cell).
As you say, there is a lot on their plate already.
Red:
I honestly don't think it is a good candidate for para/quadriplegics.
My best guess is that it would NOT work in that indication because this is a situation where the entire spinal cord has been partially or completely severed somewhere along the spine.
To the point, regrowing damaged synapses between cells in the brain (Alzheimer's) is a very different problem than "re-attaching" a severed spinal cord.
Just a guess...
Exceptional post, coach.
If you add a little comment about AXSM, it might cover it all!
Just an FYI: In biotechs, once the trial is completed (all patients tested), it usually takes 6-10 weeks for the data to be internally scrubbed, collated and statistics run and analyzed.
Posters on this board have estimated a news release on the data in the range of mid-August to late September, depending on when the final patient is tested.
If you look over the past 10 days or so, a poster named "doc328" gave a really good explanation of this:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149017815
First, the results are expected in Aug/Sep.
If the trial results confirm the subgroup analysis, and reaches the same p-value (~.01), then:
- There will be a major upgrade in the share price. The market cap should trade in the range of $500M-$1.5B within the next 6 months IMO; others here think it should be higher than that, since it would be the only drug shown to REVERSE Alzheimer's.
- NTRP may sign a lucrative partnership with a major biotech/pharmaceutical company, reinforcing how significant the results are, and probably pushing the market cap even higher.
- NTRP may choose to go it alone, in which case they would raise some more cash, and then talk with FDA about whether Bryostatin is approvable based on the current Aug/Sep results (less than 50% chance IMO, but others here think there is a decent chance of this), or whether they need to run a large phase 3 pivotal trial
- NTRP may choose to sell the company, which I would expect would be for multi-billions.