Here’s the press release.
(STARES at today’s news)
*^()&)*(&)*(&)*( I DON’T EVEN.
(RUNS around yelling incoherently, but happily.)
THIS… this is what we’ve been waiting for. Ocata is officially now going to start Phase 2 of the AMD study.
There’s so much to be said here… it’ll have to get done later on… but for now… HAPPY. Just plain… happy. 🙂
Check this out!!
The EU agrees to fast track desperately needed meds.
The EU is pulling FAR ahead of us with this one. The European Medicines Agency (EMA) has decided that trial medications for incurable and untreatable diseases can be fast tracked and approved for use with small populations– IF they’re getting great results. (Such as the success that Ocata has shown with its stem cell based cure for the most common cause of blindness in the developed world. HINT HINT HINT.) That is not happening here.There is no genuine fast track for medications that show that kind of desperately needed promise. The “breakthrough status” that is available for these types of meds is very inadequate.Very few medications have ever been granted this status until Phase III of testing; real promise might be shown much earlier than that. And quite honestly, this situation why I decided to support the Right to Try laws in the U.S. As imperfect as they are (and they do have issues, beyond a doubt) they may provide pressure for the FDA to adopt the same thing that the EMA has now done.
It’s easy to say that adopting the same policies in the U.S. would lead to little regulation, and that is a real concern. But look at what’s happening here. The EU is not somehow throwing out all regulation.In fact, that’s just what they’re avoiding with this decision. Here’s why. If you or a loved one ever have a terminal/disabling disease, reason and logic will go straight to hell. You won’t care what’s regulated or what isn’t. Believe me, you won’t. You’ll do anything at all that might help– and that means you’ll be vulnerable to some really bad choices. People do make those questionable choices right now, and there are more of them available than ever before (illegal stem cell clinics being a good example.) The only way to stop this is to give desperate people other options.
The EU is doing what they need to do in order to accomplish this. We can do it too, and we have to. We can’t play these games with people’s lives anymore here while the rest of the world figures out exactly how to help those who suffer.
Posted in Laws and Politics, Right to Try
Tagged cures, EU, European Medicines Agency, European Union, incurable, miracles, ocata, patients rights, right to try, stem cells
I’m leaving for the conference today, yay! I’m really excited about this one. There are so many important issues in this area with stem cells right now, especially with the Gordie Howe story. So much of the stem cell field is unregulated right now the second you get out of the U.S., and that’s an issue that has to be addressed. Here’s the link to the pdf of the agenda for the day:
Symposium Flyer 2.12.15 (1)
So, I was posting a summary for my book on the NaNoWriMo Facebook page, thinking that it sounded over the top… stem cell-based cures for horrible incurable diseases within 2-10 years, that kind of thing… well….
There’s no link for this, because it is insider info from shareholders who went to Ocata’s quarterly meeting in Boston, which was not open to the public. (There is a LOT about Ocata in the book– they’re the biotech company that just changed their name from Advanced Cell Technology.) Ocata is the company developing the first cure (or even treatment!) for age-related macular degeneration, a disease that slowly causes blindness for 30 million people in the U.S. and Europe alone. The interim published results for the clinical trials have looked great, but as far as when this treatment might actually come to market… it’s everybody’s guess.
But in the quarterly meeting… several attendees have all said the same thing. The drug already has orphan treatment approval for a genetic disease caused Stargardt’s, which has exactly the same effects and eventually causes blindness. But it attacks much younger people, including children as young as six. (Yep, six years old.) AND… the CEO of Ocata said that the drug will be available in the U.K. in 2018. We don’t have absolute confirmation of this yet. But it’s apparently what was officially said at that meeting.
One of the lines of thought on the forums is that the date might be earlier for AMD approval in the U.S, even quite a bit earlier if the drug is fast tracked here… we just don’t know. But this is INCREDIBLE!!!~ There has never ever been any kind of treatment for Stargardt’s before, and now there will be, and it will be STEM CELL BASED. As of now, that will be the first drug approved anywhere in the WORLD that is embryonic stem cell based.
YES! IT’S THE START OF A NEW ERA IN MEDICINE!!! And it will be in the book!
(sorry about the capslock…
Posted in Great News
Tagged advanced cell technology, amd, cure for blindness, cures, embryonic stem cells, investigational drugs, miracles, ocata, robert lanza, stargardt, stargardt's, stem cell, stem cells, treatments, trials
Stem cells. The hope, the hype; the successes, the failures; the frauds, the triumphs, and the miracles in the making. It’s all going to be here! Oh, okay; ALL of the information in the world about stem cells is probably NOT going to be found here. 😉 But if I can find it out… will be. There will be much more content here, including the story of just why and how I became so passionate about the entire issue of stem cells and regenerative medicine. I can honestly say that some of what you’ll read here is unique and cannot be found anywhere else the world. So just keep watching this space– some incredible things are coming up!