The only thing A2-73 has shiwn is safety and that too in 25 or 20 patients. Water injection can also show safety but it does not mean efficacy and cannot be used as medicine.
While blaming regulators is in fashion - the simple logic is - the role of FDA is to regulate the process of drug approval and ensure that the drug approved is safe and has right efficacy.
Bring a drug and show efficacy - FSA will approve it. Pharma companies are not able to come with drug with efficacy so there is no approval.
If dr M was very confident about his drug, he would have pushed for a trial in US but he is not able to get approval for even Rett.
Let’s wait and see when he starts dosing AD and PDD patients ad we will know when it will likely end
Polar, let's hope some esteem members of the FDA have traveled to Australia to meet and speak to trial participants, caregivers, Dr. Mac and other professionals in the field of geriatric care.
If they did that, maybe some of their questions will be answered.
Let's face it. We are our own worst enemy. We have allowed a culture of dishonesty to permeate the BP-FDA-Swamp and now we cannot believe a word that is spoken or written. The trials have been marginalized. Stat experts spend days arguing about the significance of certain abstractions when most of us just want to know the truth.
An old Wizard of ID cartoon comes to mind...We have found the enemy and it is US.
Why have we allowed a culture of liars to exist? We have FuDsters who go nuts and get paid to confuse and misdirect. And we allow this. Why?
How about being able to believe what is reported and to be able to use technical papers delivered at WW conferences like AAIC as fact based truthful evidence. Why have we allowed this? What are we going to do to kick some ass to stop it? Until we start (here and now) to get this under control we are kidding ourselves and we are part of the problem.