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Talon...here is new design link...look familiar?
https://www.newsweek.com/irans-new-fighter-jet-copy-us-plane-1960s-military-experts-say-1085804
T-38, thanks. I keep getting hung up on the difference between guiding and leading. I'll get over it. Curious if the latest Iranian AC design looked familiar to you. They just announced it a couple of days ago. BR
Thank you for information on IND process. I am familiar with it. Also, thanks for confirming that the FDA's method for establishing priorities is based on whoever walks in the door next.
Curious. Does anyone know the basis for "who's Next" in the decision/processing queue at FDA? Is it public welfare? Is it total systemic cost? Is it politically based on who is in office at the time? Is it the number of patients/cost per patient/overall healthcare system costs?
Is there any score sheet anywhere that tells us when a priority will be set for AD trials for example? (not only AVXL) Maybe when we get an idea then the details being speculated here can be considered in some sensible context. Who is in charge?
I do see an opportunity for big impacts being managed in a rational and positive manner. No one here really has a clue on why these decisions by FDA are taken? We assume there must be some one in charge w/a plan. If that is true then we sure should be asking why FDA spent the last 20+ years using process methods that produced nothing of value for treatment of AD, and BTW where is the FDA plan for all other CNS priorities or do they just wait for someone to walk in the door w/an idea?
Sure would be nice to have a rational-fact based-status discussion, including any facts on process changes and relevant impacts. Just like these were serious issues.
Kentucky 123 says..
More on connecting FDA dots.
https://www.fda.gov/medicaldevices/digitalhealth/
Some of us here have reviewed how the FDA MUST KNOW they have process issues. Of course all of that is to be expected during periods of significant technological evolution. We might argue such concerns are particularly notable in CNS disease-land where complexity/criticality and innovation are always up next...bottom of the 9th, w/bases loaded and two outs...seems to be the ongoing game plan scenario.
If one does a little checking(google searching) around. Guess what, you're right. The FDA is in a process kerfluffle and it is impacting what gets done and when and who does it and when will they get funded and all the systemic rest. Not to mention the political and BP human exponents in every CNS decision.
So the GOOD NEWS is, we are right, the BAD news is we are right. The use of other systems (countries) to conduct arguably the most important testing of the century (CNS Multiple indications) may not be pretty but it is an important and correct choice (IMO). With the belief that there will likely be multiple treatment refinements going forward we have little choice. If we wait around for the FDA to fix itself we will all be dead. Good move M., execute the plan.
Very, Very NICE work Tredeherpete. Hits all the buttons.
Happy to have an opportunity to finally agree w/you on something.
This truly is about the/a problem solving process. IMO, when all the bright highly skilled industry and FDA resources begin to explore solutions using new tools and methods they will rewrite the books. When alternatives are evaluated using AI tools and verified by suitable virtual/clinical methods the entire development process will be compressed.
I suppose it is obvious but I will say it anyways. IMO, the Precision medicine (ala AVXL methods) completely GUTS the established FDA/BP/Political swamp hypothesis method. The first successes of this new process represents the Functional Equivalent to storming the FDA strangle hold trial ramparts. We are on the point and it is going to be a tough struggle.
https://finance.yahoo.com/news/edited-transcript-avxl-earnings-conference-013428392.html
IMO, he describes a process for treatment of CNS diseases. He describes the gene identification links. IMO, this alternate problem solving process to that of proving an hypothesis (T/F) supported or not by requisite statistical rationalization. Considering the complexity and criticality and now available alternate problem solving models it is hard to see how BIIB will continue down it's Amyloid hypothesis path much longer.
On a brighter note, Dr.M. is describing a well defined path for problem solving which at some point obviates the need for massive, time consuming trial process alternatives. When this process approach has been more fully practiced for efficacy will other "untreatable" CNS diseases be studied in the same manner? Obviously, the answer is yes. Does this mean AVXL presents a value added SP double hit? We present both an effective AD treatment investment along with a solutions process for the analysis and treatment of other CNS diseases. IMO, that is what Precision Medicine offers. It's a process and it works.
tradeherpete, thanks for an excellent assessment of the situation we see at FDA-NIH. There simply is not alternative explanation for why the FDA and our Healthcare system has not produced what the country needs over recent decades, in spite of the taxpayer money and resources thrown at it. IMO, it is as simple as...They like it just the way it is and do not want to change a thing. If they wanted to change/improve, they would.
Kentucky says:
Kentucky says:
Bourbon...Keep Calm, we got this.
Xena links:
Biostockclub:
Suggestions for a clinical-cognition test to determine if you might be in line for an A2-73 tablet or two. If you can watch CNN for more than 10 mins you might want to start taking A2-73. I suggest this would be evidence early cognitive skills decline. End point in trial would be when repeat the test process watching CNN and you start screaming at the TV and throwing things. Then you know you're fine.
Xena wrote
In the domain of.."we don't know what we don't know", do they make the case for CNS cellular homeostasis knowns/unknowns? In fact, is mid 70's onset of AD only a symptom of something we do not yet have a name for?
tredenwater2....excellent post w/many big thoughts way outside the box, as they should be. I am puzzled about (Blah..Blah...Blah) thinking also.
OFP, not sure I can help you understand what you obviously do not want to accept as factual. The use of facts derived(under previously agreed to conditions) from work/source (RWD-RWE) according to a documented plan, which has been previously agreed to by FDA is done every day. Go to FDA homepage and search on their definition of competence for further understanding. ende.
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119469.htm
This paper is the tip of the iceberg. In general any journey into FDA conforming processes is not for the faint of heart. 21 CFR part 210, 211, and 820 each refer to validation and retrospective application of the rules. There is no shortage of defined-written guidance. It is left to the author to interpret and apply the guidance when developing the appropriate protocol as required for the defined scenario. Such discussion is well beyond MB scope.
It is useful to define the term(s) protocol in this context as a written plan which details the PROCESS to be used. That is what we are talking about is a documented process.(for example see 21 CFR part 820.75 (a-c).
FDA definitions:
Validation: Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality objectives.
Validation Protocol:A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
Retrospective validation Validation of a process for a product already in distribution based upon accumulated production, testing and control data. CDER definitions:
Again, not a trivial task but one that is certainly doable and which is done often enough in the real world today.
riaguy:
Pres. trump spent a few mins. discussing R.T.T. last evening in W.V.. He sounded informed and enthused about new drugs/treatment opportunities for people who otherwise have no chance to live. He did not mention specifics or types of diseases or treatments but the point was made that he supports the R.T.T. concept.
IMO, that kind of public message/statement often invites/indicates or directs those who are working on or close to taking risks then they are "unofficially" provided cover to do so. Regulatory bodies like the FDA are often tied to political structural endpoints, this will also be tied to the, "Shat happens" new science model.
In any case, B/C of the decades long history of failure by the FDA to lead or even effectively recognize the dynamics in healthcare by at least getting out of the way, we can sense that significant change is way overdue. Trump sees this, IMO. Instead of just covering the axxes of the insurance/BP/healthcare system, maybe someone will actually lead. Just imagine AVXL opportunities in such a CNS context.
Standby for indicators, IMO. His comments are rattling around the hallways in Maryland about now. Set defcon 2-Fast Pace.
In fact I have been there (doldrums). On an A/C carrier in Atlantic near Cuba. Ship had to build speed to 30+knots over the deck in order to launch A/C. Flat seas, strange.
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.
Contents
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: