Instiladrin and Rebiotix

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anonymous

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Just curious. What people have heard? Reaction from customers? Other opinions? I believe they are good buys for Ferring but we will need new management who know what they are doing. Also heard no internal Ferring people for Instiladrin
 








anonymous said:
assuming the product is approved its a non antibiotic treatment for c diff. It’s fast tracked and breakthrough designation by FDA because there are few options and 30k people die per year.
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Doubtful it is approved. Did you see that the phase II didn't pass primary endpoint? Zinplava is on the market, and that will start to turn the C Diff/fecal transplant situation upside down. Read up on that. As well, Seres has far more going on than Rebiotix does.

And furthermore, Ferring as much as says it's not for the current clinical trial biologic drug. Here's what the Ferring press release says:
"This is a long-term investment for us. We see it more as an R&D investment that creates a complete, mature microbiome platform rather than product acquisition from which we are looking to get short-term financial gains," he said.

"We will grow from this rather than say it all hinges on the success of the front-runner project."

The pair declined to provide financial details of the acquisition, saying that the pair had been talking for many years about a deal. Rebiotix will become a wholly owned subsidiary of Ferring and will maintain its name, structure, location and people.

What was the cost of acquisition? And what's of value in the pre-clinical R&D bucket?
 


listen crap-head (get it... the drug is made from crap) who cares how much because we have a new and very promising product. If Zin-what ever you stated was working than FDA would not have given fast track status
 


anonymous said:
listen crap-head (get it... the drug is made from crap) who cares how much because we have a new and very promising product. If Zin-what ever you stated was working than FDA would not have given fast track status
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It did not meet the primary endpoint

See this link to the trial results. https://idsa.confex.com/idsa/2016/webprogram/Paper57591.html

Methods: Patients were randomized to receive either: 2 doses of RBX2660 (Group A); 2 doses of placebo (Group B); or 1 dose of RBX2660 and 1 dose of placebo (Group C) via enema with doses 7 days apart. The primary end point was treatment success following 2 doses of RBX2660 compared with 2 doses of placebo.

Results: A total of 150 patients at 21 sites in the US and Canada were enrolled in the study. Of these, 127 patients (Group A: n=41; Group B: n=44; Group C: n=42) were in the intention-to-treat population (mean age 61 years; 62.2% female). Efficacy for Group A was 61% vs. 45.5% for Group B, P= 0.152. Efficacy for Group C was 66.7% compared with Group B (45.5%), P=0.048. Efficacy of Group A and C (63.9%) vs. B (45.5%), P= 0.046.
 






anonymous said:
Yes, same thing happened with Seres. Whatever. It won’t be a commercial product. Series maybe
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Mixing shit with some excipients and administering by enema or any other way isn’t going to approved. Give me a fucking break. Look at the Rebiotix Patents - goddamn joke.

The only reason Ferriing bought this outfit is to leverage some data Rebiotix has with the microbiome informatics deals Ferring has done.

I would be surprised if Ferring paid more than 50M. I’m sure investors barely got their money back. Fact that terms weren’t announced means that Rebiotix didn’t get that much. Rebiotix would have pushed for terms to be released if terms were so great - their CEO is such a narcissistic egomaniac.
 


anonymous said:
Mixing shit with some excipients and administering by enema or any other way isn’t going to approved. Give me a fucking break. Look at the Rebiotix Patents - goddamn joke.

The only reason Ferriing bought this outfit is to leverage some data Rebiotix has with the microbiome informatics deals Ferring has done.

I would be surprised if Ferring paid more than 50M. I’m sure investors barely got their money back. Fact that terms weren’t announced means that Rebiotix didn’t get that much. Rebiotix would have pushed for terms to be released if terms were so great - their CEO is such a narcissistic egomaniac.
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Hey genius, the product is designated Fast track, break through, orphan by FDA. There about 5 companies in the race for this "shit" with Rebiotix in the lead position. Do some reading on your industry and stop being such a dickhead.
 




anonymous said:
Hey genius, the product is designated Fast track, break through, orphan by FDA. There about 5 companies in the race for this "shit" with Rebiotix in the lead position. Do some reading on your industry and stop being such a dickhead.
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Why is Rebiotix in the lead? The Ferring purchase announcement surly would have touted this fact. Instead it says:
"This is a long-term investment for us. We see it more as an R&D investment that creates a complete, mature microbiome platform rather than product acquisition from which we are looking to get short-term financial gains,"

Right there, Ferring basically says they aren’t buying for a product.

Oh, and didn’t realize orphan, fastrack, and breakthrough meant that the FDA automatically approves.

FDA is placating all the hype. It’s a sure Sure Thing, golly Uncle Buck’s turd soup cured Thelma Lou!!

They designated it as a biologic drug requiring clinical trial and allow stool banks, and are hoping like hell it all goes away. Last thing they want is another Factor-8 scenario. They’re caught between a rock and a hard place. Safety wise, FDA would much rather see a well-characterized Biologic like an antibody (zinplava approved). And at the very least Seres current treated fecal material. (Alcohol-treated, spore harvested, established pathogen kill profile for the process)

You do realize the issues with donor screening?
 












Spoke with one of my urologist who happens to be a investigator for Instiladrin. He said the trial is taking longer than expected but results look awesome. Said it’s a winner
 



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