Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
$NTRP Announces Positive Top-Line Results From Phase 2 Study of Bryostatin-1 for Moderate to Severe Alzheimer's Disease
can somone interpret this from twitter a few minutes ago:
Best strategy at this very moment is short commons and buy 2x call at higher strike, ie, short 100@14.9 and buy 2 $5c for 1200.
can someone explain the basics again-
who actually decides what price the share will be sold? Is it a broker, or a company representative? At some point, after a bid is made, someone has to say "Ok i'll take it". The entity doing the selling must know that if they can hold the price a bit higher, they can end up making more money for the company - or is it simply trying to sell as many (quantity) shares as possible?
FDA so-called "fast fail" trials are just nomenclature, they don't actually mean the trial is expected to fail fast. They are a method of demonstrating efficacy with a quick turnaround to reduce overall resource burden.
RE: molecular data showing how PKC activation can actually increase APP
i think you are right, the papers do indicate the inverse relationship between PKC-E and APP etc. However, you are also pointing out that PKC may indeed be an entirely new area of intensive research parallel to plaques and tangles. Makes it even more likely BP would be interested in a synergistic approach with existing failed compounds.
It's severe Alzheimers. Of course patients are expected to die from the illness. Multiple patients died during the memantine trials.
with this volume and movement, i wonder if something leaked
Yawn
we've been through these before
IT'S NOT A CONTROLLED STUDY
DO YOU NOT UNDERSTAND HOW CLINICAL TRIALS JUDGE EFFICACY?????
SMALL UNDERPOWERED STUDIES ALWAYS HAVE LARGE EFFECT SIZES, LOOK IT UP
WHAT USE IS A BIOMARKER IF THERE IS NO CONTROL GROUP?
in terms of a synapse restoring drug, if the drug does what it says (and certainly there is preclinical evidence to support this) the moment the bryostatin is in the brain it is promoting restoration of "roads" between neurons. The brain itself has years of information encoded, so in theory by fixing the roads, the circuits connect and things, even if momentary, may dramatically improve.
The epileptologist told me patients with severe Alzheimers are screwed. Nothing can save them.
The endocrinologist told me patients with severe diabetes are screwed. Nothing can save them.
The infectious disease doctor told me patients with severe tuberculosis are screwed. Nothing can save them.
The cardiologist doctor told me patients with severe heart failure are screwed. Nothing can save them.
blu1- very interesting post. can you tell us about the double blind placebo controlled trials that Anavex has run on 273. Thanks
Anavex. Isn't there an Anavex board to discuss matters related this company?
I think the way these contracts work is it's "free" but for the context of the phase 2B trial. Though the current synthesis method is provided for "free", it is an expensive process.
Just to clarify, I am only talking in the context of why an open-label extension was not immediately offered to patients as can be common with other small, easily synthesized small molecule drug trials.
Yes, agreed, but the current trial is not using that process. Seems like they would want to transition to the new process first before offering the open label extension is what I am saying.
It seems like the biggest barrier to open label indefinite treatment is that this is basically a custom, highly expensive drug to produce with a relatively higher administration route in a patient population with an high mortality/morbidity rate - seems like it would open the company up to a high level of risk! Right?
For the more experience traders:
when folks are short selling, they may be able to "borrow" shares to sell to other (at the higher price) but when it comes time to close the sale you need to then buy shares to return.
is it possible what happened is that since liquidity is so low, that they were having trouble finding shares to buy at a lower price, so they had to keep dropping the price to get at stop orders to free up these stocks?
There are doing a great job of shaking the trees. But then in retrospect, I kind of wish i sold in the mid 20s and bought back.
Phase 1/2 Studies
Does anyone know if they ever published the efficacy data on this phase 1/2a trial?
https://clinicaltrials.gov/ct2/show/NCT02221947
it's been completed for a while, i understand that they published some of the tolerability data.
Does anyone think this is just warrants being exercised?
it's no use, these are secret sales. I have a 500 block of 21.5 limit and it's not going through.
Edit- just went trhough for 21.35
any suggestions on what price today to buy in at?
I'm a lowly retail investor, very confused about what is happening. But overall, am not worried, thanks for the tip about the stop orders, damn, didn't realize that's how they shake the trees!
what does "eom" mean?
The most reassuring thing about thestreet.com publicity is that now we have some national media exposure, we can assume that things are getting priced in a little better. I would assume less big ups and less big downs from here, especially if no options and shorts are scared.
Sure, not at scientific meetings but they have peer reviewed papers and abstracts at meetings.
The reality is they are trying to raise money, good for them to go out there and toot their horn and get investors. They realize they may have the biggest drug in the history of pharma and if they can avoid being bought out, they are going to try.
I'd also add that if this truly is a breakthrough product, we are getting in cheaply so to say, but it's also true that growth potential is also massive following clinical approval of the drug - if that's when others want to hop in.
A pharma buyout is unpredictable, but I assume favorable for whatever company we will own down the road (unless we are bought out)
Hold on to your horses!
What is going on today? Are these retail buyers? I hate it when the stock moves to quickly up!
Xenalives,
I respect your posts, I'm successful scientist, but a novice investigator. You have been fairly negative on the retail stock.
It seems like as a retail buyer you could have bought in the mid-12s and today sold at 22? What am I missing? I know that volume is low, but are you saying that if I tried to sell my stock today, it wouldn't go through?
This is not necessarily a stupid question, but actually quite interesting. Synaptic repair, if anything, in a healthy person might actually lead to worsening cognitive and emotional symptoms. In severe ALZ the brain is literally falling apart and connections between neurons are very disruptive. That being said, and this the mystery of how the brain works, there is still a lifetime worth of information encoded somehow across the brain. The brain is also a master (over time) of rerouting information and load balancing.
From a very high level, if you take the compassionate use cases at face value, the dramatic improvement can be explained as follows -
the highways and roads between the "old" cities in the brain are rapidly being repaired - once they are even rudimentary repairs in the place - travel and communication can immediately begin again (since the information is already stored). So best case scenerio with this model, is that a patient with AZD get's close to their previous baseline (which may appear dramatic) but can't necessarily improve on top of that since we are restoring roads, not cities.
Not sure if this makes sense, i can't say I've had this though before, but have been thinking about those compassionate use cases and the rapid recovery.
Now eventually the "cities" may fail (and this may be the final consequence of the plaques tangles etc) and then it doesn't matter how many nice new roads you have. ..
my apologizes to the board - i don't know whose post I read about the 6 drug and 3 placebo patients, must of been the compassionate use trial or something? THe Phase IIb study protocol is EXCELLENT that is a classic gold standard drug trial.If this is positive, expect huge interest from pharma including $$$ to reformulate the drug in the best, most available form.
Hi SFWolf,
This is where I share XenaLives opinion. The current formulation of the drug gives certain advantages for a phase 2b trial. With an IV formulation you know for a fact drug is being delivered and you can get very accurate blood/PK levels. This provides crucial information on pharmacodynamic data - i.e. what level of drug in the blood correlated to what level of clinical improvement. There is still the mystery of how much of the drug is getting into the brain, but I assume they have some data on this as well.
To go to a Phase III is very difficult with this setup. The reason they only have 6+3 patients is because it is extremely expensive to do IV drug studies which tend to be done as an inpatient with nursing support, monitors etc. If they are unable to make an oral form of the drug, you are multiplying the IV infusion form of the medication x placebo/drug group x at least several weeks. So you can see the cost factor scales up significantly.
Having an oral form for example, greatly reduces costs (and complications) however, you now have to start from scratch on figuring out bioavailability of the drug etc. If the IV numbers say that you need a very high dose of the medication to achieve a clinical result, then they may be SOL if the oral form can't achieve this without extremely high doses which will likely cause toxicity.
So you can see the quandary that they are in. My guess is that they have a good product, probably even efficacious, but the delivery of the medication is causing some headaches. No one wants to spend 10x the amount on a phase III trial when the final product ends up being a hospital/nursing home only infusion therapy which will be cost prohibited. They are probably looking at other forms - i.e. intramuscular depo, pump delivery etc, but none are as easy as oral form. My guess is that they are screening their "bryolog" compounds library to find another hit, but even if they find one, they have to really start the process completely over - as there might be thousands of these with different toxicity profiles.
i could keep rambling but hopefully this gives you a sense of what the internal dialog is like.
This is a really insightful post, it's the same problem pharm has with mild depression. Mild (even moderate) depression spontaneously resolves, so it tends to amplify effects of drug trials. When you are trying to get an FDA drug approved - this actually plays against you in a placebo control trial, because the placebo response is so high. So they do a plcaebo lead in.
THat's why they start with open label trials in 2b since without a comparator the spontaneously improved patients make the mean look better than it is.
In a placebo controlled trial you get hosed.
The ERP is a just a measure of brain activity of behavior. There is no comparison group. Why would it be immune to bias? Would heart rate be immune from investigator bias?
That's just sales talk really- a P300 in a randomized controlled trial would be different.
That's the trouble with an open label trial, it seems like this part is hard to communicate, you don't know what the change in the P300 is from. It very well could be totally normal variation, but in this case in the context of the disease normal variation = disease progression.
When you ask how can you see those results in placebo group
that's exactly why you have a placebo group
placebo groups can have 10 to 40% responder rate in neuropsychiatric disorders
in fact, some trials will do a placebo lead in in order to "wash out" placebo responders
When you ask how can you see those results in placebo group
that's exactly why you have a placebo group
placebo groups can have 10 to 40% responder rate in neuropsychiatric disorders
in fact, some trials will do a placebo lead in in order to "wash out" placebo responders
P300 ERPs are basically the 1950's, easiest to measure, non-specific marker you can possibly use. Hell, you can download BCI200 and do P300s at home by just counting numbers.
The key words for an objective test is target engagement. A non-specific marker like P300 is not target engagement, it is just a marker that is probably more similar to a PK value at best at worst in an open label trial, just normal physiological variation.
Blu_1
a controlled trial is superior to an open label trial.
if you finish a 2+ year open label trial with 200 patients, you still need to do an RCT
i agree the NTRP trial is small, but they are ahead of the game in this regard.