see how to end Iran war below:
Nearly 70% Of New Drugs Now Win FDA Approval With Just One Study
How FDA Drug Approval Standards Quietly Slipped Over Nine Years
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the loss is balanced among trial arms, a proper research question, only if there is proper randomization sequence generation (e.g., stratification, blocking and block size if used and defined who computed the randomization sequence) with bullet proof allocation concealment to arms (how the sequence is hidden from trial researcher and head and all involved), proper control group for comparisons, well defined selection criteria, defined design e.g. is it parallel group, crossover, allocation ratio, and framework (e.g., superiority, equivalence, non-inferiority, exploratory) etc…again, ONLY if….note only if there is blinding of researcher, subjects, outcome assessor, trial implementors or researchers, statistical analyst etc., all team (ideal to be triple blind and tell me how you did the blinding not just that you blinded), to mitigate performance, detection, selection biases, blinded to treatment allocation, proper statistical power computed and statistical tests to assess differences among interventions as well as harms, to uncover a difference IF one is in fact there, only if there is minimal or no funding or conflicts of interest, ensure there is a proper registered PROTOCOL in place (no changes to protocol and if there are, must be documented, date and time), anonymized data, defined primary and secondary outcomes and primary outcomes that are PATIENT important, proper ethical approval, defined STOPPING rules to guard against RANDOM highs in the interim analysis driving you to stop too early when the declared benefits would have fallen away HAD you continued to sample size, a defined INTERIM analyses (note again, how do you plan to handle data loss) e.g. imputation, LOCF etc., and only if there is NO selective outcome reporting, only if proper statistical tests are used to discern a meaningful difference IF one exists etc., how you collecting HARMS data, and any subgroup and sensitivity analyses planned, distinguishing pre-specified from post-hoc analyses and ONLY if these are on tap can we ever take ONE study to inform policy and clinical decision making. so if you did not know, now you know Bobby Jr. do not go asking morons like Malone this stuff, ask McCullough, Thorp, me, Hulscher, Risch, Ladapo, 2nd etc. …we know…we are purists experts, not the idiots you have around you at HHS and FDA…only if studies are conducted this way is there robust estimates of effect that can stand scientific scrutiny…clear clear eligibility criteria…often overlooked, the selection…note if too tight reduces external validity….extrapolation to general public…
Bobby Jr., I am giving you a class here and chose to…I know you are a lawyer and while I thought brighter than the average moron out there, even some technical knowledge, you need some schooling, work based on how terrible and sub-optimal FDA, CDC, HHS is performing with you on deck as lead…
so now you know RFK Jr., now you must end this madness and get FDA to become the premier regulatory agency it SHOULD be and it is currently no, since Trump 1.0 and before. IMO FDA must be taken down to the studs, burnt down, I mean send all employees home and literally burn the building down, invoke the spirit of Publius Cornelius Scipio Africanus and the second Punic war against Hannibal where it was reported he salted the earth, so salt the fucking earth where FDA campus stands and let us rebuilt, for the American people and where we can Bobby Jr, where courts and judges and juries can help, if they find guilt of deaths by FDA policy even before Trump, then we hang these fuckers high! we spare none, in the ballroom. a mass hanging, of folk from CDC, HHS, NIH, NIAID, ask me to help hang some after judges and courts say hanging is the penalty. we let the law unfold and discharge justice.
always.
other than that Bobby Jr., huge hugs and love my man, I still admire you, and wish you peace and a good life, even as I find you a complete abject failure as HHS head. failure. you should resign.
Nearly 70% Of New Drugs Now Win FDA Approval With Just One Study
How FDA Drug Approval Standards Quietly Slipped Over Nine Years
In A Nutshell
Most new drugs approved by the FDA in 2024 relied on just a single clinical trial, down from a majority backed by three or more trials in 2016.
Industry funding for the studies behind drug approvals jumped from under half in 2016 to more than 80% by 2024, while NIH-backed research nearly disappeared.
Trial results are also slow to reach the public, with delays averaging well over two years despite a one-year legal deadline and almost no enforcement.
The study cannot prove the 2016 21st Century Cures Act caused the decline, and it does not show that today’s drugs are less safe.
When a new prescription lands on a pharmacy counter, the assumption is that it went through years of testing, checked and rechecked before ever reaching a shelf. That assumption isn’t as safe as it used to be. A new analysis of every novel drug the Food and Drug Administration approved between 2016 and 2024 found that most reached the market on the strength of a single clinical study, a sharp break from years earlier when the agency typically wanted evidence from three or more trials.
Iran:
US Has Used Nearly All Its ATACMS and Up to 80% of Its THAAD Interceptors, Reports Say
Two separate reports published on August 4, 2026 say five months of war with Iran have consumed virtually all of the US Army’s long-range precision missiles and between 38 and 80 percent of its THAAD interceptors. The Pentagon disputes the figures.
see my offering below to end the Iran war:
I again offer steps US can take to pivot the US military to the 21st century asymmetric war posture (clearly as what has been done here has failed) and my view on steps POTUS Trump can take to solve this devastating clusterfuck of a war:
First, 4 urgent points (I have used from brilliant minds) worth considering to enhance, upgrade the military’s ability to meet and overcome the enemy of today and tomorrow:
‘First, the United States needs to invest in counter-drone technologies, like those that Ukraine has developed in its war against Russia. The lack of such defenses is one reason that the vaunted U.S. Navy has been unable to prevent the closure of a vital waterway, the Strait of Hormuz.
Second, the United States needs more of its own cheap, disposable weapons like one-way attack drones and unmanned ships. Although much of the war in Ukraine has been fought by mass-produced drones, the Pentagon is pouring money into much more complex equipment, including pilotless “wingmen” that can fly alongside a piloted plane.
Third, the country needs larger and more flexible industrial capacity. Until recently, a single factory made all of America’s Tomahawk cruise missiles, and there is a constant shortage of Patriot missile interceptors. Congress should pass laws that help the private sector build up its manufacturing capacity. The Pentagon, for its part, needs to stop buying so many of its weapons from just five big weapons makers and start betting on dynamic tech companies that can quickly adapt.
Lastly, the United States needs to collaborate with other industrialized democracies. Mr. Trump’s pleas for help in reopening the Strait of Hormuz from the very allies he spurned at the start of the war is just the latest proof that America can’t go it alone. In the years ahead, keeping pace with China’s economic and military expansion will require collaborating with like-minded democracies.’
In the end, if USA homeland was attacked, I would help defend it, personally, I will take up arms, if it were attacked, if Canada were attacked or my home Caribbean island nation but that did not occur here, Iran did not attack USA and we do not go bombing another nation to ‘help out another in its bombing’ or ‘in case they ever attacked’ or based on a supposition or theoretical risk especially when our own US intelligence said no attack was imminent and that Iran had no nuclear weapons and was not near completing one and posed no imminent threat. Our own intelligence. I guess this is why Tulsi DNI was placed on the naughty chair day one of the bombing.
I am totally against what USA did here bombing Iran. Based on all that was known, Iran did not pose the threat to warrant this. I know this could have been dealt with differently. I want POTUS Trump to bring our precious troops home, no more blood shed all sides…
I stand by Trump.
I stand by this great US nation.
I stand by my flag.
The main thesis I am expressing is that the safety and security of Israel is paramount and must not be breached. Ever. So is the safety of USA and of Iran. I mean all three. In this debate. Yet I am an American (and Canadian and Trinidadian Tobagonian with Cuban and Middle East heritage) who loves USA. US stood and must stand as the last beacon of hope. And lead. Must not now digress to be the world’s bully because ‘we have bigger weapons’. No. strength is NOT that.
My proposed solution I offer to POTUS Trump (for we want him to win) to get out of this Iran war that we the US wrongfully started and given that it seems the US is being held hostage by Iran and now trapped and desperately seeks a way out (given today, after 2-3 months of bombing of Iran (and an US asked for ceasefire), they Iran, have remained intact and by all accounts have grown stronger as
1)the Iranian brutal regime which I do not support, and cannot support, remains in place and some argue with even more hardliners and thus we may have caused a worst situation…
2)their Iran’s ballistic and drone assets are largely intact as reported by even our own US intelligence…
3)they retain their enriched uranium (60%) that could be taken to weapons grade (90%)…
4) HAMAS and Hezbollah and other terror assets remain and
5)they now control the Straits of Hormuz (when prior to bombing they did not as ships passed daily unimpeded)…having our US sailors mill around warship decks playing shuffleboard…
My 16 point resolution plan (as a simple lay person interested in no more blood shed and US leading the way to solve this, despite US have a wrongful role in initiating this clusterfuck):
1)that POTUS Trump must fire functional dry-drunk sexual predator SECDEF Hegseth immediately (and the other drunkard deer-in-the-headlight FBI head Kash Patel, what an embarrassment) for badly misguiding POTUS Trump into this wrong Iran war
Do not forget this lady in the pedophilia issues, may have explaining to do under oath sometime?:
2)POTUS Trump to declare a victory, some form of it, and say that you accomplished what you sought to e.g. degraded Iran’s military, reduced its capacity to wage war with Middle East neighbors etc., and take an off-ramp; if they say in media that you lost, accept that for you did actually; if they say the bombing was illegal and wrong, accept it for it was
3)The US to end the bombing now and military presence around Iran
4)Removal of the Iran port blockade by US; Iran to release and not militarize the Strait of Hormuz immediately or commit to not do this in the future; no blockage of the Red Sea by Iran; no attacks on commercial shipping or any types by Iranian gun boats or military
5)Trump to bring all precious US troops home now; maybe get some additional concessions to exchange any spies or people held both sides…win win if possible.
6)US to apologize for the deaths by the US missiles of the 170 little schoolgirls in Minab…that was a mistake (I cannot think it was deliberate so will not say that or entertain it unless I can be shown this) yet tragic, very painful; admit it if we were at fault for the healing to begin; offer compensation to the families.
7)Iran to pay USA for our dead soldiers and we to pay them for their dead children and innocents. The war was wrong. We have to compensate each other
8)USA and Iran us to return to the negotiating table, and fire idiots Kushner and Witkoff, two of the biggest negotiator clowns in history. They are one-sided and biased
9)consider crippling economic sanctions for 5 years on the nuclear issue on Iran yet the debate must begin now as to why Iran must not have a nuclear weapon and why they COULD, given other nations are allowed to; lift any economic sanctions on commercial issues in the economy so that they can have economic growth and rebuild their infrastructure; Iran to agree to work collaboratively and peacefully for the next 15 years with the United States as a partner, with routine bi-annual high-level meetings (issues around trade, economies, military, security etc.)
10)work to get Iran to transfer the enriched uranium to China or Russia with joint yearly inspections including the USA where USA must sign on and be a partner to the inspections…China, Russia and USA to inspect…and relevant UN agency…but Iran retains ownership, it’s theirs. But not to build bombs. At the same time, get Israel to sign on to the NPT and declare the weapons they may (or may not) have…
11)Iran to declare no building of a nuclear weapon for 15 years as a bargaining tool, should they move to do so; all nations Iran, Israel, Pakistan et al. to commit to and agree to never use nuclear weapons on any neighbors, ever
12)Iran to declare no support of HAMAS or Hezbollah or any other terror assets e.g. Houthis, Islamic Jihad, Wahabists, Salafists etc. in Middle East and for good; end that, I mean a commitment forever, particularly never to use such terror assets to attack Israel or US and in fact, anyone
13)US to leave Iran’s oil and assets and resources alone, it belongs to Iran. Same for all nations in the world e.g. Greenland, Canada, Venezuela etc.; US to leave all assets and resources of all nations, it does not belong to us and all nations must do the same, China, Russia, India etc. all powerful nations must stop this quest for unbridled hegemony. Taking other people stuff. By force.
14)put on table that the US will reduce military bases in Middle East by half to 80% to complete as a negotiating tool etc. If Iran wants zero bases, this could be on the table to negotiate.
15)USA and Iran to commit to no military attacks on Iran for 15 years. Iran to agree to no attacks on Israel or United States for 15 years (homeland or territories or bases etc.). Ideally a commitment by all sides to do this forever. No attacks forever. firm commitment. Forever where Israel is to be safe and Iran and all nations in the region. Again, all such nations to pledge no military attacks for ever. The security of Israel is paramount as is Iran as is USA etc. Nations must commit to peace and end any and all terror related attacks on respective peoples. For good.
16)Iran and US to work together and enter into bi-lateral workable financial and energy resource deals and projects over the long-term to drive jobs in both nations e.g. US can commit to help develop Iran’s energy infrastructure while Iran commits to supply as need may be, the US with any energy oil and gas needs etc. Again, another piece to add to negotiations to help it.
These are my preliminary suggestions to be iterated, added to etc., what are yours?
Long live USA, greatest nation, long live the stars and stripes flag, our nation, our military, peoples, long live our POTUS Trump, I support, & I continue to want Trump’s success! I want God to grant Trump favor and cover and protect him, grant him gracious mercy and help him! Give him success, and that means not by war, but by doing the right thing here! Bring them home! End the failed Iran war and bring our troops safely home…
Also, Steve’s response was to this article I shared (and that photo next is some precision bombing of our bases in Kuwait (rendered it now inoperable as radars etc. blown up) by Iran, for a nation that the Trump administration is obliterated and has NOTHING’):
Alexander News Network (ANN): Trump’s War 2.0 for America is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.
“We may not want to admit it in the US and the Trump administration but: “China is America’s Military Equal Now And In Any Future Fight, Marine General Warns
Faced with the rapidly growing China threat, the U.S. has to start hardening its bases now, said Marine Lt. Gen. Stephen Sklenka.”
The Iran was has shown the limits today of America’s military power and the weaknesses. It is shocking.
“Epic Fury (Iran war) offers some sobering lessons, Sklenka noted. While the U.S. is able to pour forces into theater via uncontested skies and largely uncontested seas, Iran was still able to inflict a great deal of pain on America and its allies during the fighting. And, it still is, economically through an ongoing closure of the Strait of Hormuz. A fight with China would be far worse, Sklenka cautioned.” https://www.twz.com/sea/china-is-americas-military-equal-now-and-in-any-future-fight-marine-general-warns
GiveSendGo | Dr Paul Alexander Needs Our Help
Please know that when you use my code PAUL10 at the RESOLVX HEALTH website each and every sale greatly supports me and allows me to continue fighting!!
Company name is RESOLVX HEALTH
Alexander News Network (ANN): Trump’s War 2.0 for America is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.
Alexander News Network (ANN): Trump’s War 2.0 for America is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.
and
Please consider support of a good PATRIOT company (in this PATRIOT economy) Drs. McCullough, Risch, Thorp, myself support (they are our sponsors), The Wellness Company; see the emergency preparation kit (key component being antibiotics you were denied by doctors, pharmacists, governments during the fraud COVID), first aid kit, travel emergency kit, contagion control kit etc. Please consider the SPIKE SUPPORT (spike protein DETOX dissolving spike from mRNA vaccine, this is critical to remove spike form the mRNA vaccine/and DNA viral vector) formula with NATTOKINASE as well as the triple formula (SPIKE SUPPORT, BROMELAIN, CIRCUMIN)
If you wish to give a donation to help me, you can at:
Zelle:
sr7283@gmail.com
Nearly 70% Of New Drugs Now Win FDA Approval With Just One Study
dont bring one study to tell me you approving at FDA with one sub optimal bogus study...come on RFK Jr. we can use observational research too but it must be consistent and proper robust statistical and procedural controls and adjustments. we dont have that at crooked pharma Pfizer Moderna bought out FDA