Replies to post #31929 on Vivos Inc (RDGL)

[solmer]

Dude, I like to read the ADMD board even though I don't post much and Let me tell ya, you sound like one weird sob.....flipfloper

[dsoulliere]

You say you sold 14 million shares Friday because you saw the 10q. That's impossible most of the sells were before the 10q came out. So either you sold before the 10q and now are blaming that or you're just flat out lying about selling. Either way something's not right and you can't get a story straight.

[LOAD_ADMD]

So now that your wife made you sell, this stock is shit. Sail that boat in another pond buddy, the rest of us will take care of the fload.

[thephantom1]

Got it. Thanks for letting us know you won't be buying back in. Sorry to hear that though.

[Diggnun21]

Boatlife, there are two companies that beat them to the punch? So the FDA approves more than one company that has a similar medical device....follow me here. Now, AMIC has a device that is more unique then either of them. Are you saying the FDA won't approve it because it has a product similar to two other companies?

Your logic is flawed. First you say FDA will only approve one company with a device that is substantially equivalent to another. But then you say, there are two companies that already have this product on the market. Think real deeply about what you just posted.

No wait, I won't play mind games. I'll answer for you--the FDA allows multiple different companies to put similar products on the market. And none of the three you are referring to are exactly the same. Especially, AMIC Radiogel- Y-90. That's how it got its patent bro.

[Diggnun21]

Boatlife: You should DO your DD! It's a good thing there are two companies that "beat them to the punch." That means we have substantial equivalence. Though not one of these companies or products is exactly is the same. AMIC Radiogel Y-90 has a patent!!!! You don't get a patent if you put forth a device that is exactly the same as one already approved and you don't get de novo approval unless you can prove substantial equivalence with another product already FDA approved.

[MilkWai]

Just because two companies "beat them to the punch" doesn't mean ADMD cannot succeed. Ultimately the deciding factor on which device comes out ahead is cost. I'm talking about everything. How much does it cost to manufacture? Is the administration quick and easy? Is there a big hassle afterwards?

One big downside to TheraSphere is that it is NOT biodegradable[1]. That is a huge concern because how would the body remove it? Is there a danger of accumulation? What happens if there is an accumulation?

The fact that TheraSphere is NOT biodegradable separates it from SIR-Sphere and Radiogel. But I can't comment any further on SIR-Sphere and Radiogel because I don't know what polymers it's made of. The formulation of the polymer composite matrix is probably considered reasonably different than the resin used for SIR-Sphere although function is probably still about the same. And now it comes down to cost. All of the things mentioned above.

So in my opinion, would this get FDA approval? Very likely. There is no reason why SIR-Sphere would be approved and Radiogel won't be especially if ADMD can demonstrate to the FDA that the matrix it uses can hold up and is biocompatible with the body. At the end of the day, SIR-Sphere and Radiogel are probably doing the same thing with reasonably close efficacy and safety levels. Think MSFT vs AAPL sort of competition.


[1] http://www.accessdata.fda.gov/cdrh_docs/pdf/H980006b.pdf