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I think an address is needed as well. What did they include in their last end point submission that the FDAs response seems as if they included next to nothing other than brief symptom relief?
Investors should be irate
With the pace they typically work this could take months just for a resubmission.
This is now 2 rejections from the FDA. 3 strikes you’re out
“The FDA recommends that the Company’s proposed primary symptom-based endpoints should cover the evaluation of time to sustained recovery assessed over an appropriate duration, evidence of subjects experiencing resolution of COVID-19 related symptoms and the element of sustained symptom resolution”
Why wouldn’t this have already been included with their proposed symptom relief endpoints? This is common sense.
Incompetence
Timbbberr
This PR is just a jumbled word salad.
What kind of end points did they submit that the FDA responded back with a no, use these and resubmit of basically what you would have assumed their already submitted end points were?!?!
What scenarios can play out here soon:
1. End point change denied. Game over
2. End point change approved. MF then prepares for submission for unblinding of data to DMSB?
3. More information and discussion needed on pending end point request? Delay continues while revive scrambles yet again?
4. End point change approved and unblinded data show’s positive efficacy allowing unblinding of all data and quick submission to FDA.
Any other possible scenario im missing?
Agreed that’s just a target date for the FDAs response. We might not see a PR good or bad until they digest it etc. the wait is killing me!
Same. I will grimace and hold and hope
Thats my gut feeling. Not a no, but another delay for some new request kicking the can down the road for another few excruciating months
On the bright side if they’d already received a no from FDA they would have PR’d it likely late this afternoon leading into the weekend. Hopefully we can still pull off a miracle next week
What would that put the share price at for a $2 billion buyout? $3-5?
Ezra throws a bandaid on a cut artery. What an abomination this is.
At what point is this criminal?
LOL just throwing sh*t at the wall and hoping it sticks with these PR’s
Agrees. I see it two ways:
1. MF is trying to diversify and make themselves look like a real company and hence attract a BP buyout.
2. He’s burning cash on these side projects knowing deep down they will be denied on Bucci and he is trying to not put all his eggs in a losing basket.
I pray it’s the former
Watch the videos people. This is how a cornered rat acts after being confronted.
This should be major national news yet the major media outlets will ignore it as they receive so much ad dollars from Pfizer and BP.
Disgusting
Now down in a Bloomberg mention?! Wtf
The only emerging situation is boosting as many people as possible so Moderna and Pfizer can make their billions
Only hope is he some cheap distribution channel overseas on standby ready to go. A salesforce won’t be needed if the approval is announced via traditional press etc. Just needs Cardinal, McKesson etc ready to jump on board as DC’s for the pharmacies etc
Skyrocket to $8 a share. Sit back and profit. I’ll take it. Just get SOMETHING done at this point
If these other antioxidants were worthless against omicron Bucci might have just been slightly less worthless. We won’t know till they unblind the damn data
MF had said in the past he will sell Bucci on the open market in the event FDA denies.
Anyone know what that looks like? Id assume will not be able to sell within the US. Focus on 2nd & 3rd world countries for off label use?
Will this help the share price at all if they can maintain revenues via this method? Or does the SP tank?
Scares me that this gets more likely
Until it is approved and used for all of those ailments he mentioned it is just his opinion. Not denying the science but we’ve seen the struggles from MF and RVVTF with the FDA. Nothing is guaranteed
The drugs been around forever if this were the case it’d be used for these things. Lets worry about covid first otherwise this is useless
75 days would be a soul crushing wait
Are they not allowed to work during hannakuh? Get off your asses as do something kosher or not for f*cks sake
Get yourself back to break even on this one at least in the event this plays out. From there you’re playing with house money
Dumb question but how would one purchase this offering with warrants? Via the firm they hired?
If I purchase a ticket will he be splitting it 10 for 1?
Mid December?! How is this shit not ready to go already? What have they been doing the last few months? So inept
If Im understanding this correctly type C meetings are just written responses to requests or demands? So MF can’t even roll in there with experts to argue their point? Only submit a written response or request? This stinks to the high heavens.
Seems the market is fed up with the constant and consistent moving of the goal posts
Hit a 52w low today at one point. Wild stuff on somewhat neutral news
Market doesn’t love the news
Oh awesome so it never goes away
Assuming I had the latest and greatest variant last week. 10+ days later and I still have a cough and nasal congestion. Felt like covid for 3-4 days then broke, yet still have lingering congestion almost two weeks later
That’s when the lawsuits fly
I wish I could laugh at this