Lineage Cell Therapeutics Inc (LCTX)

[DeepDive]

I hear you, C., with respect to Cox's assumption the 501(K) will facilitate a rapid approval in months. I sure hope it does.

But, with all due respect to Cox, there are couple of issues here.

a) If my memory serves me right, the AI algorithm found a DRUG that's protection has expired which seem to have this wondrous rejuvenation ability. We don't know what it is (while the company registers its IP).
b) if it is a Drug, it is probably metabolized. or be biologically active. while I am not expert in all things related to drug approval, I can see a problem with calling this a device:

What is a Device?
...
Devices cannot achieve their ends by chemical action or be dependent on metabolism (5).
... https://www.sciencedirect.com/science/article/pii/S2452302X16300183

.

c) There is another issue here, and that is the therapeutical use is very different than what the drug was initially for. My common sense says that before the FDA will approve any miraculous claim, no less than pure magic: Scarless regeneration! it will demand to see some sort of validation trials, to say the least, and they will be close to Clinical Trials.

The FDA went guns blazing after neutraceutical makers that said had inflammation reducing properties with Antabine maker that anecdotally Cox recommended again and again (until it went bankrupt).

I can't imagine the FDA will allow anyone making claims about scarless regeneration (or growing of limbs) without a good size trial. (Even if Cox hopes so), certainly without any details or data from the company.

anecdotally, I am taking another biotech that is using 501(k) for Psoriasis remedy. the original use was AIDS drug. They are waiting for Phase IIb clinical trials now, following successful IIa trials. Phase I was waived. no so with PII, III. 501(k).

Look, Its OK to speculate and get worked up. Hell, I hope Cox IS right (though he is not a specialist in drug approval process). He is, after all, in the business of selling newsletters and must keep the reader base worked up and paying.

Until I see more data about this from the company forgive me for choosing to take this speculation with a pinch of salt.

I think we will all be smarter within a couple of months, and reserve the right to say you were right.

Let me tell you, though, If you ARE right by chance, I will be making lots of money... Im very Long.

good luck!

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