Now you are being mischievous, or seek to be ongoing perverse & toss up anything possible.
To be a contrarian as you see it.Understanding that being contrarian is also good as you perceive it, but this too far.
Safety is not in question at this stage for DXB200.
Re trials and exclusion criteria-
Even if DXB200 can benefit these advanced ill patients who have other diseases & significant co -morbidities illness —excluded patients, although would be nice to charitably think that these patients could benefit from DXB200 rather than continue to inevitably decline towards dialysis, these patients are excluded as this is of course not a benevolent trial but a very serious trial now in phase 3, to determine for if can measure a significant response.
Without confounding individual factors or where the patients is just so ill and will be confounding results even more for DXB200 than with all of the included trial patients who are also significantly ill and compromised.
Showing a response of significance is already very difficult in a very ill cohort.
Co- morbidities, and in decline, the prognosis for all of the patients in the trial or who are not able to be in it—is sadly not good.
This is why they are considered for this trial- because existing care cannot adequately help them.
In another forum it was explained about exclusion criteria.
Exclusion criteria are despite the fact that these patients could personally individually benefit from the trial treatment and that their doctors and they might very much wish to be considered for the phase 3 trial.
The trial design is to carefully, ethically, and as accurately as possible measure for an outcome.
Less suitable patients with significant co- morbidities or other advanced organ failure in this case for DXB200 trial - are excluded from the trial.
Trial design is a meticulous & careful process, though the patients all are very sick and standard of care maybe not be available or work for them.
Also in trials where the drug might be adjunctive or given as a carefully planned control to test for if can show superiority, or at least not be lesser in response and efficacy -to standard or existing drug care for instance .
Every trial and situation unique.
But must be with less harm, or lesser or minimal or removed negative effects for the patient with the trial drug or treatment , successfully in some way seeking to treat or control their condition .
ie. be worthwhile enough.
Etc .
The alternative drug trial treatment is deemed to be very much needed for efficacy as well as its already measured safety, and be able to be used equitably where currently insufficient good and safe and practical dosing treatment existing.
*Safety is not in question- and in fact can be already seen to be an overriding factor of benefit for the test trial drug treatment* .
And also the drug be able to be given simply on its own or suit as adjunctive treatment, compared to other available drugs or treatments.
All obviously.
I am sorry , apologies to the forum as I am way out of depth here- but in principle this is true.
The patients as currently treatment exists- cannot be treated or treated adequately for their condition with any or the standard of care.
(Or SoC available not enough to help them /or can be harmful or they not able to take/ or they are not able to have anymore of SoC due to their decline now and non- efficacy of existing treatment. etc )
But also however, as I understand it —
**Always compassionate use can be considered and occur behind the scenes, for any current trial treatment drug **
With strict privacy and non- disclosure clauses, such that the treatment drug can be given to the patients who do not meet the trial criteria and are excluded, if & where the patients doctor requests to use the drug, with the company.
It must be judged from tests that can be beneficial individually for the patient and with how the drug is meant to be used & being tested for, and then the drug can be provided under ethical guidelines and careful parameters at the dose, rather than denied.
These patients might in many ways be the luckiest recipients of the trial drug.
The company is not allowed to report or disclose compassionate treatment use or ongoing results of the trial drug.
The company gets to use and collect data and results from these patients and dosages etc.
As Dimerix also does currently with the patients who are continuing to take DXB200 beyond the conclusion of the phase3 trial for them, including patients who had actually only received placebo during the trial.
Nina reiterated this week that many patients so far have elected to continue to take DXB200 beyond completion for them in the phase 3 trial —presuming that overall benefit to them ongoing has been & is being demonstrated ongoing.
Clearly it is not futile or harmful overall for them to be taking DXB200 routinely, still, by choice for them individually and their treating physicians.
Re Aspirin- again this was terrible & flippant to me, example. You continue to refer to and brush over boxed warnings.
Sounding as if a drug that has been around forever is not to be disputed as fairly much ok, despite a very long list of adverse and acute life threatening risks.
No one should keep popping aspirin pills, or any drug pill without it being prescribed. Nor ignore safety warnings and precautions.
Aspirin use at judicious dose is mostly for a headache or one- off injury or use for pain or precaution, usually with at least pharmacist discussion & only by adults/ no one who is pregnant etc.
Definitely not for children under 12.
Wrt drugs - children are not mini adults.
There is a lot that they cannot tolerate and that can lead to highly adverse effects with just one dose or treatment.
I simply say- not to be indifferent regarding drug boxed warnings although they can frequently read as being alarming.
The warnings are there for good reasons.
Children, women, compromised, during pregnancy, post-cancer patients inc those with heart failure- very difficult to manage and successful fully treat for a condition such as advancing renal disease.
Most anti-inflammatory drugs are contraindicated for kidney diseases and are very much known to be harmful & cause damage, irreversibly even for the kidney.
Wrt DXB200 or any drug for when it maybe be approved- there is no such thing as a safe drug.
DXB200 is not a new drug, and as I understand it has been given to many more patients than only in the Dimerix trials to date.
It will be given to many more patients prior to approvals anywhere in the world with trials to continue .
Data will build.
(Apologies typographical errors previous posts- posted only quickly from my phone )
(20min delay)