GBA Presents: House of Gummy-!

[stonedinvestor]

Sure. So on the EU and CHMP, so as we've shared previously, in the EU adopted initially a negative opinion. We strongly disagree with that opinion. And I think the basis for that is we are in a randomized placebo-controlled study, met our prespecified primary outcome, showing a slowing in the rate of progression on the ALSFRS-R. We've also observed a difference on overall survival. And that data, of course, led to our approval, but there are full U.S. FDA approval and our approval with conditions in Health Canada. So we believe we have a data package that should, in our view, support approval. But of course, ultimately, this is up to CHMP.
So we submitted for reexamination. That's roughly a 4-month process, under which 2 new repertories are assigned and review the application. We submitted that shortly after we got the negative opinion. So you can expect that near the end of this year, we'll hear back regarding that opinion.

 

[stonedinvestor]

Ananda Kumar Ghosh

Congrats on the quarter. So I have 2 questions on the ALS program and one for the PSP. The first question is basically some of the question which keeps coming from the industrial community, and that would be if PHOENIX is a required confirmatory study for accelerated approval of RELYVRIO and what -- if it says, then can FDA initiate a process to pull it off from the market? So any clarification on that would be great. And then I have a follow-up question on the ALS program and then a PSP.

Justin B. Klee

Sure, and thank you for the question, Ananda. And yes, I mean, first, there is a full FDA approval. There's no condition of the PHOENIX study. In Canada, it's an NOCC, which means a Noticing Compliance with Conditions. And again, our expectation in Europe if there's an approval, is that it would also be a conditional marketing authorization, and the condition there would be PHOENIX. So we continue to run the PHOENIX study. We'll have those results mid- next year. That's a very highly powered study. And we and I think the ALS community are looking forward to those results. But from an FDA perspective, it's a full FDA approval.

 

[vanzandt]

We will go down 3-8% and stay there------------> sideways.

From 4100 in May... to 4500

 

[stonedinvestor]

"Open lower Monday & Then A reversal and rip higher."
- The Fiddler

 

[stonedinvestor]

THIS IS

HOUSE OF GUMMY-!

 

[vanzandt]

Between 3rd and 4th Q. That would be, umm, exactly now.

Do me a favor ON, and spell it out for Stoney.
Have I not been saying, especially before Biden was able to kick the student loan can down the road, that mid Q3 and Q4 would be lower? Unfortunately "Q3" and "Q4" doesn't work in the search function. I even tried Google's site search. It sucks too.

Ya know I could call the exact closing numbers for the SPX for the next 4 Fridays in a row, and be 100% right to the decimal point... and poor Stoney would still be in denial.

 

[Overnight]

Do me a favor ON...

Ya know I could call the exact closing numbers for the SPX for the next 4 Fridays in a row, and be 100% right to the decimal point... and poor Stoney would still be in denial.

Quid pro quo. Do ME a favor and don't call them unless they are all higher from here.

 

[stonedinvestor]

Van love your post from page 20 --a 1 week outlook
You are funny. Every GBA certified call is at Marketwatch !!

GBA No 1.

Stop pretending to be old Van it's not working and nobody believes it.
You've seen Gaudi my friend now you know.
You know what I learned when I saw Gaudi...

You are are not the be all, in fact you are hardly importnat.
We exist because art demands it. Free your mind and your body will follow.

Join ME! Spoiled Children be dammed, don't be mad at hem.. they can't handle the real
cash we have given them.

 

[stonedinvestor]

SPECIAL GUEST-

 

[vanzandt]

Quid pro quo. Do ME a favor and don't call them unless they are all higher from here.

Well if anyone here knows with certainty what has been posted, you do. Unfortunately I can't control the direction lol, only the calls.

It's hard to understand Stoney's jealousy regarding this. One would think he'd be a little more positive.
I mean I could care less, but he is in utter denial. It's an interesting insight into the human psyche actually, at least as internet forums go. But whatever.