New PR out this morning!
Sentiment: Strong Buy
They always consult with each other probably because... they are the same person. Most on this message board have dogface on ignore so, he uses the other Id to get his BS messages out.
In the past they would release press about everything. Now they aren't reporting anything. I'm beginning to think that they want the PPS low for some reason.
Sorry but you are wrong. This trial is an open-label trial which means the patient can talk all they want.
Great find & thanks for the post. You can find this by going to the abc 27 news website and typing in " What are the odds? 2 Midstate men picked for stem cell trial " in the search box. The other patients name is Thomas Mundhill.
I also would expect that the ALS association who has donated generous portions of money to fund these trials wanted to further rule out patients who were showing signs of bulbar systems from being responders of this therapy.
Yes that's correct. Neither one of the first 2 trials were designed to show efficacy. They were designed to show safety. My main point was that I believe that they used patients in phase 2 that were showing signs of bulbar symptoms so they could rule them out further as being potential responders and that this would explain the rapid decline in the non-responders. After watching and listening to the webinar I believe my theory to be correct about the non-responders. The next trial will be designed to show efficacy.
Dr Feldman stated that the phase 2 trial has been determined to be safe. She stated that the cervical surgery is proving to be challenging for the doctors but it is safe
Between minutes 34 through 36 that the patients used in the phase two trial had no significant bulbar symptoms with some patients showings greater arm weakness than others. She didn't say no bulbar symptoms at all she said no significant bulbar symptoms. That for me suggests that some patients was showing some signs of bulbar symptoms but wasn't full bulbar symptoms. This would also correlate with dr. Johe's statement in the press release from March stating that patients in phase 2 showed fairly similar preclinical conditions as the patients in phase 1 did. So, isn't it possible that some patients were showing signs of bulbar symptoms and this could explain for the rapid decline in the non-responders?
I said I was stating my belief. I wasn't able to watch the presentation how to I've been on the AMA website and can't find the link to the webinar. If you would be so kind and post a link to the webinar it would be very much appreciated thank you you have a nice day support and I said I was saving my bully. I wasn't able to watch the presentation how to I have been on a n a website And can't find a went to the webinar. If you would be so kind and post a link to the webinar it would be very much appreciated thank you you have a nice day
Go back and read the press release from March where dr. Joe states that the patient used in this trial had similar conditions as the patient in phase 1
Then I believed that they used bulbar patients in the phase 2 trial. That would explain the rapid decline in the non-responders
It also wouldn't surprise me If, Big Pharma has something to the short attacks that's happening to start up companies like, Neuralstem.
an additional indication.
Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests.
The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition.
The priority review voucher program for rare pediatric diseases is revised and extended.
The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices.
Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption.
“Health software” is defined and, with certain exceptions, exempted from FDA regulations.
This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services.
A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products.
Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs.
This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.