Good info- thanks for digging in on that. But let me please raise a few questions per last part of the statements:
1) Is it a definitive "given" now that Mirror is "outside U.S. now to save money"? I don't know if that's an "official" company PR and given position, is it? The original Pr regarding Mirror was that is as follows: "The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF)."
I see the words NORTH and SOUTH America? I don't remember any official company statement that Mirror is now outside U.S. exclusively (N. America being Canada, U.S., Mexico, Central America)? But did BHRT ever say, the U.S. is excluded in this Mirror trial- I just don't remember that being officially stated anywhere? Could be wrong- but is that true and a blanket statement now?
Also, I don't think the FDA cares where you're doing the trial nor do publishers of medical journals- if you want it to be in the "big leagues" - from what I read on that .gov site, you register it. Again, I don't get any implied statement when I read that site that says in effect, "Hey, if you're doing your trial/study/data collection off-shore/outside U.S. borders, but still want FDA approval in the end, or major med journal publication, then just skip all this registering and getting the NCT number assigned stuff".
I'm just not getting that in my read of it? The way I read it- if you want to come back here one day, and sit across the table from the FDA and seek their approval of your product, then they want it done their way, in their system and all- no matter where you're collecting your data, etc. That's my read on it. I'm not sure how/why those concluding statements were made at the end of the post- seems like a pretty broad, lose interpretation of what they sent back? Again, that's my opinion.
Just the implications to how it could/can hinder your possibilities at being published in major journals, too me, is enough reason alone? In other words- WHY NOT REGISTER? It's free, it's relatively simple it appears- unless of course they didn't get granted approval by the reviewing committee(s), including the live human one? Other than that, what's the down side to registering? It's a win to be registered with no down side that I can see? Again, why register this "Macular" whatever trial, but then drop your big, flagship, phase II/III trial off the board? WHY? For what possible reason would that be a good choice/decision? I guess I'm still not buying the "it's outside the U.S." or the "it only helps to enroll people, we don't need it, it's voluntary" - it doesn't pass the smell test to me.
Last update we got was one, one single patient enrolled and that was from July last yr. If it was being tracked/updated on the .gov web site, seems we would know more, or the updates would have to be more timely.
Also, I'm still not sure what to make of that last part of the PR from the "one enrollment" announcement- it's odd to me, as if mentions FDA "hold" and "reviews" and so forth, and I don't think BHRT ever really answered or explained that in detail- not that I'm aware of?
"July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients."
That verbiage to me is confusing? They say they "intend to continuing enrollment"? As if the trial might be "on hold"? And then what ever happened to the Marvel, part 2 J&J and so forth? I don't think that's ever been mentioned again, has it?
More questions, than answers from my end? But that's me?
AI
