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Scooter McCabe

04/07/21 8:11 AM

#157175 RE: daemon57 #157169

Yes Nader moved the CC back to actually have news for the CC.

I'll say that again. Nader postponed the Conference Call to have news to report. That means the Conference Call is/was going to be fluff. Now don't get me wrong, getting a letter of intent is all fine and good. But there is one piece of the puzzle missing. Approval.

Everything hinges on approval. There are several companies with agreements to distribute in Brazil pending approval. So it's a horse race. First one there is the first one to the market share.

Could Brazil go with a study that uses only 16% of it's patients for it's results? They could. Brazil is hurting badly enough that you would think they would. But Brazil has been hurting for some time and it has not rushed through other drugs or bypassed clinical trials.

So we had news like this in the past. Sounded great, next few days shorts came in and knocked the price down because well, no actual news.

An EUA is the only thing that keeps the price up, also the only thing that gets revenue going too.

Good luck.
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Grip it and Sip It

04/07/21 8:43 AM

#157184 RE: daemon57 #157169

What do you infer from the PR? It’s simply a distribution deal. Nothing more...are you predicting approval to be mentioned on call? If so, why not PR it?

How is this different than Samsung deal? Deal to manufacture but nobody to sell to.
Vyera: deal to license and get $87M in milestone payments but FDA wouldn’t file BLA

Now this comes out. It doesn’t mean a thing if there isn’t a buyer. I’d keep the optimism in check. Nader has been a fairly predictable failure with these CC’s. Just my opinion from five years of watching these moves

Grip
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that_little_voice

04/07/21 8:55 AM

#157189 RE: daemon57 #157169

I disagree. Why not announce this after market yesterday on the call? Did they need to rush to get it signed?

Also, wonder what the terms are. Did they pay like Chiral? How will they fund a Covid, cancer and Nash trial? Does this mean the FDA has shut the door and they are now looking at other countries for approval?

Brazil following regulatory clearance. This line sticks out to me. Does this mean approval after full trial or EUA? If EUA, have they submitted the application? Don't recall seeing a PR about it. How does this affect Hungary? Does this take focus away from Philippines?

Is this another Mexico and China deal?