Frankly the CEO of NWBO made a mistake in stating that they would file in the UK by a specific date, and then delayed that date a few times. I don't know precisely what Missling has said, but don't believe he's indicated a date certain, then failed to do so. Frankly in many ways I think it's better to file and not say anything, then announce acceptance. If the regulator requests some change in the submission, none would be aware of it, the change could be made, then when accepted it could be announced. NWBO took the other path, announced their submission and didn't announce acceptance, which some companies also do.
NWBO's MAA was 1.7 million pages, anyone have an idea of the size of ANVX's submission. I suspect it's substantially smaller as I believe the NWBO trial had several issues that had to be addressed, though in the end the results should be judged on overall survival, and that really should be the gold standard for trials in deadly diseases. Alzheimer's, on the other hand, often becomes a greater burden on a patients personal support system as patients diminished capacity to do things add ever increasing burdens on the support system.
In my treatment for leukemia I met a lot of really positive patients and Drs. especially at City of Hope. I'll admit however I did see a lot of patients who didn't appear to ever leave their beds, and frankly I don't know that they ever did. In all my treatment I was encouraged to get out of bed and walk, and I did so, though sometimes not as much as they'd like. At times I was not to leave the room, for at least a few days, but most of the time I was encouraged to take laps around the floor. At one point they grouped the patients willing to come and had games, exercises, etc. and frankly I wish they had more of that. If those who were safe to do so could get together and have meals with other patients in a descent setting it would be far more appealing than eating in bed or from a chair on the small portable tabletop you work with in a room.
I know that space is a premium in a hospital, but if patients are more satisfied with their stay, I think the space needed to make that happen would be very worthwhile and might actually result in shorter stays as patients exercise more in walking to meals, exercise groups, etc. Of course some can't, but for those who can, the results could be positive.
A friend who's a retired surgeon was comparing the treatment his wife got in France for a broken arm with what would have been done here. There they set the bones with a couple screws, which were to be removed several weeks later, it hardly got in her way. In the hospital she walked from place to place, X-ray, operating room, recovery, and in leaving the hospital. If here she'd have either been transported on a wheelchair, or gurney, and would have been cast and immobilized for a substantial period of time. The point is, they permit the patient to do what they can without crippling them, while we prevent the patient from taking any risk, like walking, to avoid the possibility of a legal action. The cast is more protective, and restrictive, while the screws permitted an almost completely normal life. Here, even when you're being sent home to walk in your home, climb stairs, etc. when released from a hospital, surgery center, etc. you go in a wheel chair to your car. Why?
Gary
