Safeplus International Holdings Ltd. (ACAI)

[sunspotter]

"The FDA should fast track this technology to help save the lives of sudden cardiac arrest patients...now...how many must die needlessly while they procrastinate?"

I'm not sure it's entirely fair to accuse the FDA of procrastination. After all, as far as we know, Biophan have not made any kind of approach to FDA to discuss approval, nor have they even started the process of generating the human clinical studies data that would allow them to contemplate asking FDA for approval, let alone fast-track status.

No, while doubtless FDA has its flaws, it seems somewhat harsh to castigate them for their failure to divine, presumably by telepathy,that there exists a large and needy group who would benefit from marketing approval for Myotech CSS. I'm referring to the group who are dying .......



to make a quick buck out of this whole sad affair, that would of course be the long-suffering shareholders.

The good news is that it's entirely within BIPH's control to get approval for this device, which should be a Class III medical device, best as I can determine:

"STEP ONE in the marketing process is to make absolutely sure that the product that you wish to market is a medical device, that is, does it meet the definition of a medical device in section 201(h) of the FD&C Act. For example, the product may be a drug or biological product that is regulated by a component in the FDA other than the Center for Devices and Radiological Health (CDRH) and for which there are different provisions in the FD&C Act. Or your product may be a medical device and is also an electronic radiation emitting product with additional requirements.

Classify Your Device

STEP TWO is to determine how FDA may classify your device - which one of the three classes the device may fall into. Unless exempt, FDA will classify your device. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain FDA clearance/approval for marketing.




Selecting the Appropriate Marketing Application

STEP THREEis the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in additon to marketing clearance."


http://www.fda.gov/cdrh/devadvice/3122.html


Step 1 and 2 are very straightforward. It's step 3, particularly the generation of "clinical performance data" that seems to be the hold-up. I will confess to not understanding why this should be, given that they've talked about it for years, they raised millions of dollars in the past to pay for this specifically, and they had all the Medtronic money. And yet ever since BIPH got involved, the technology hasn't been near a human (I am beginning to feel sorry for all those poor dogs, although at least their deaths have generated a few puff PRs for BIPH).

Why don't they "just do it"?

Answers on a postcard please to SEC.