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Re: PlentyParanoid post# 212920

Monday, 01/15/2018 5:29:23 PM

Monday, January 15, 2018 5:29:23 PM

Post# of 403599
Now, perhaps we can get down to the reason I decided to put the question about this product to the board.

I actually sent those links to management back in March of 2016. What management replied to Cabel was similar to the reply I received. LE’s reply makes perfect sense to me, so I’m not disagreeing with the logic behind it.

However, if you read your statement and management’s statement together, doesn’t it remain “possible” that they are telling the truth and the FDA is unaware that it works because it is “unproven” as far as they are concerned?

Several of currently marketed OM treatment are approved under medical devices, which mean they really don't have any proven (to FDA), biologically significant effect






“Obviously, if this was "effective" in treating OM it would be unethical for the hospital or FDA to allow placebo in an SOM trial. I don't think I need to say any more than that. “




I was hoping that the second half of the OM trial would match the interim results because it seemed like they had a line on a potential partner if the final results matched the interim results. When they were not quite as good, I felt it was worthwhile to revisit the matter.

I suggested it might be a worthwhile idea to order a sample of Prothelial and have Dr. Sonis run it through a couple of hamster pouch models. One with Prothelial alone and one with Brilacidin suspended in Prothelial.

To me it seems like a way to accomplish a couple of different things at once.

1. Prove Mueller is exaggerating their claims and notify the FDA so they can act on the matter.

2. Test Brilacidin in a device that is already approved for sale by the FDA to see if the improved surface retention time improves Brilacidin’s effectiveness.

My thinking is it would be pretty cheap and fairly easy to test.

What I’m wondering is how others here feel on the matter? Is it a stupid idea and a waste of time and resources or is it something IPIX should pursue?



http://www.prothelial.com/about_prothelial/works.html
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