Tag Archives: European Medicines Agency

News From Europe!:)

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.

New edits on the Wikipedia Ocata page!

Hey all,
Ocata does have a Wiki page, of course, but it needed a little updating. There’s a LOT that could potentially be added because so much exciting stuff has happened recently, and today I added the news about the official completion of Phase I/II and the EMA pivotal trial designation. There’s still a lot that could be done, but I’m really glad that the page exists in the first place. Go and take a look!

Here’s the Ocata page.

Ocata Therapeutics Successfully Completes Dosing in Phase 1/2 RPE Studies

Here’s a cogent, intelligent, and rational comment to the news below:
3458qu9fqu4589q3u-!!!!! OMG I DON’T EVEN. O.o.
This moment has been brought to you by the Department of Medical Miracles to Come. 🙂
THIS IS WHAT WE’VE BEEN WAITING FOR!!! It’s the OFFICIAL announcement! Ocata can now start the second trial! They have pivotal trial status from the European Medicines Agency! This means that they can start marketing the drug after the next trial is over! It would be the FIRST stem cell based drug approved since 1956! Yes, I really DO think that we need all of these exclamation points!!!

Capslock? What capslock? 😉

Ahem. Anyway, check it out. 🙂
Ocata’s Press Release on the Completion of Phase I/II of SMD Trials