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Doldrums
From Wikipedia, the free encyclopedia
WE ARE HERE: (and everyone else is somewhere else)
"The Doldrums" redirects here. For the Ariel album, see The Doldrums (album).
For other uses, see Doldrums (disambiguation).
Look up doldrums in Wiktionary, the free dictionary.
The doldrums is a colloquial expression derived from historical maritime usage, which refers to those parts of the Atlantic Ocean and the Pacific Ocean affected by a low-pressure area around the equator where the prevailing winds are calm. The doldrums are also noted for calm periods when the winds disappear altogether, trapping sailing ships for periods of days or weeks. The term appears to have arisen in the eighteenth century, when trans-equator sailing voyages became more common. Since this zone is where two trade winds meet, it is also called the Intertropical Convergence Zone. They roughly lie between latitudes 5° north and south.
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This all reads well. BUT, bodies at rest tend to remain at rest. Once these words have gone by who is actually driving/pushing/pulling this? Inertia based on the existing system must be a factor of some consequence me thinks. What incentive does the existing body have to change? Many still hang onto the old school trials methods, we see evidence of that every day. When will the advocates of change get traction? Effective treatments for CNS diseases are stuck in this centuries old feudal-landlord-power scenario turf game as the only explanation. IMO.
rubyred links:
"Lead, follow or get out of the way."
An observation:
If we (AVXL) are waiting for the FDA or other another regulatory body to write all the rues down before we start then we are going to continue to experience this unacceptable level of uncertainty.
The, "WE ARE WORKING ON IT" guidance control from such regulatory bodies will still be the rule long after we are all dead. I think we can all see that clearly. The process guidance guys do not get the whole DEADLINE-DATE concept.
Some LEADER has to pick a date and BEGIN. Tell the process guys that is their date, now be ready with what you have ON THAT DATE B/C we going to start.
IMO, this is what happened last year and they STILL have not understood that they are out of time. Either YOU start it OR YOUR REPLACMENT will. AND, BTW , she will be a hero/heroin.
tradeherpete says
Doc328:
falconer:
thanks sokol:
Thanks bear...BTW, adult beverages are now available
Dado...thanks...I think we are looking good here...IMO, the worst is behind us.
brichnyc
Greenspam3:
Riddle me this:
What is going to happen in BP-Land when the AI, no hypothesis AAAAAHHHHHAAA flashover moment hits?
a. No FDA Secret Handshakes...wink-nudge?
b. Shat-can all BP CNS trials since it becomes clear they are a waste of money and time.
c. Hedgies start random executions.
d. Politicians start to turn on insider-deal to save their axxes
e. stay tuned cause it is all going to happen.
When Americans and the ROW start to figure out how many lives/families have been lost and how much they have been lied to they will not be happy.
This is all inevitable and there is no hole deep enough to hide in. Come to Jesus boys.
Mongoose, rumors of your passing were exaggerated I see. Nice.
Thanks for your clear message and I see it now. The old days following the scientific method of reasoning will not deliver an effective AD treatment, as you emphasize. The last 30 years or so of money and time/work should be clear evidence of that. The "Amyloid Thesis" is soon finally going to be buried by BIIB, even if they do not know it yet.
As has been pointed out here by Falconer and others..."Your/their Gig" is gone. I do not expect them to go quietly.
Now what? Well ….look way out on the horizon, see that little spec? Well that spec is a little company called Anavex and they are way ahead of the herd. We predict that at some point soon there will be a "Flash Over" of academia/research thinking/PR/knowledge/chemistry.microbiology/politics/regulatory bodies/insurance companies/and the HERD...which will give off a brilliant light as they all...GET IT.
The event/learning moment that triggers this AAAAAHHHHAAA may be trials results or a combination of micro/nano events. AVXL will be a/the leader when the dust clears. Cannot happen soon enough. Maybe we will call it a kind of Fleming moment. Today would be good for me.
Conf call was short and understated w/regard to trial details. No surprise. I was struck by a sense of...(my words)..WE GOT THIS. Not over the top but technically well informed emphasis on precision medicine. Could not help but speculate that other bio companies in this space would give for what AVXL seemingly already has. Additionally, one gets the sense of process stability. Not pumping just saying. He projects that they have connected a bunch of CNS disease dots now we will verify the science.
Maybe not CNS perpetual motion device yet but the vision is there as compared to others who by comparison seem clueless.
Text of article opens up new questions about AD and BIIB product in the queue. Also not, SP is up AH today by 2$+? really strange considering the news.
https://www.marketwatch.com/story/theres-new-evidence-that-the-dominant-approach-to-alzheimers-may-be-completely-wrong-2018-08-09?siteid=yhoof2&yptr=yahoo
Price of AD poker may be going up, soon.
https://www.marketwatch.com/story/theres-new-evidence-that-the-dominant-approach-to-alzheimers-may-be-completely-wrong-2018-08-09?siteid=yhoof2&yptr=yahoo
Stay tuned.
[quoteI believe it's changing for the better
Slowly perhaps
But headed at least in the right direction ][/quote]OK with me if they take their time to get things right but I want to see a few more people go to jail. I am convinced we have very serous problems w/corruption, there is no other explanation for what we see If other countries can get trials started then why can't the FDA?
If this recent example of arresting a sitting US senator was designed to get attention then, GOOD START. Now, FIX IT.
123tom...Thanks...when clues present please let us know....the disposition(s) of many, many adult beverages are on hold pending your guidance...no pressure.
AVXL was +12 today, HUH that is only 3 more than the Red Sox 9 game lead over the Yankees for first place in AL east. I am beginning to think there are some divine intervention messages here. NAH, just a coincidence
treden:
Kentucky, thank you. We still have a long trip ahead, but it does have to start somewhere. Why not today.
Charters comment? Does today's low volume move mean it will likely fold at end of trading or is it VFR on top?
All the best to your family, working on 53 yrs.
"A binary outcome is a general term that implies there are only two possible outcomes to a certain situation. Binary outcomes have applications in several fields, such as computer science where a "bit" is a binary outcome -- the value is either 0 or 1, and a series of bits are combined to make up data".
We will all know it when we see it. The medical/health implications and the financial implications YYUUUGE. Kind of nice to see this as a WIN-WIN.
https://www.sec.gov/Archives/edgar/data/1411906/000114420418042492/tv500347_ex99-1.htm
XENA, anyone who has done work in this space and has interfaced w/FDA or other country regulatory bodies will be aware of the massive overhead costs and technical staffing requirements that come with this turf.
Most scientists and engineers resent being controlled in how they do their work, they feel and act out against the stifled effect. So, everything gets slowed down, "what's the use", sets in and the process takes forever. They keep moving b/c they are driven on good days to get results that make a difference.
IMO, the biggest benefit of the Precision Medicine initiatives is the fact that they should open the environment to explore more ideas quickly and interact with FDA people as the process moves instead of waiting for gates and go/no go shootouts.(the risk algor.has changed). Precision Medicine should effectively address existing process issues but I don't expect it to happen overnight. Our trials are technically challenging and politically risky for a lot of FDA and clinical types. IMO. Risks usually slows things down. IMO, other countries have been less constrained and it makes a lot of sense we would be involved with them sooner.
This release says...
"The Thesis
Biogen’s fate is seen to hinge on its Alzheimer’s therapy, with the odds of success being better than 50-50, Matteis said in a note.
“From a sentiment perspective, we think the stock — in a positive or negative Alzheimer's scenario — could overshoot its fundamental value,” the analyst said.
Stifel read Phase 1b aducanumab data with more forgiveness than investors did given the treatment’s differentiated profile.
“The hardest thing to get comfort with is that the effect size — even if Aducanumab does work — is small, so, even if the drug does work, there are still exogenous variables that place the trial at risk."
Ya Think?
https://finance.yahoo.com/news/stifel-buys-back-biogen-sees-182610132.html
https://finance.yahoo.com/news/stifel-buys-back-biogen-sees-182610132.html
IMO, BIIB might be in the process of moving the AD goal posts again. If you consider money to be the only meaningful metric then they might argue it is worth a try. If true, then standby for another PR blitz at some point.
treden...partnership of some kind(s) makes sense to me too.
No debate. Getting >SP is certainly preferred. We can however learn something from the AAIC2018 BIIB accomplishment. That whole process was a technical black hole for BIIB however they were able to (remans to be seen) survive the pile of technical crap they left steaming at the podium w/nothing but smoke. Never saw anything like it. Would have said it could not be done, but there it was all shiny and sweet.