Lineage Cell Therapeutics Inc (LCTX)

[terry hallinan]

Cincinnatus,

If Premvia has a 510K CLEARANCE, how long is this doctor's study to take, when will his report be released...

As I read the PR, BTX has clearance to market premvia and the doctor's study may be accretive:

From the FDA:

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

https://tinyurl.com/yb8rh6we

On the left side of the above link is an extensive listing of approvals which I wasn't up to reading trusting BTX not to have lied to me.

I have seen no hints of sales or negotiations for sales of Premvia (which is essentially the same as Renavia) so imagined BTX wanted or needed more extensive utilization for marketing.

As for the time the doctor will take for his study, I would expect the time will take from here to eternity before the paper shuffling begins.

I would love to give you a more definitive answer but I ain't no Time Lord like Dr. Who, who doesn't exist. All know is it nearly always takes longer.

Longer than what? Longer than my patience to keep watching.

Renevia will take longer too I would estimate.

Best, Terry