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They didn't fail....they didn't meet criteria 1....but did meet criteria 2.b meaning there is more to the story.
I wouldn't jump to conclusions there champ
If they announce in the PR that the FDA redirected them to the STeP program that would still grant them expedited review to IDE than it shouldn't go lower than $0.20 in my opinion maybe even jump because it would definitely mean its going to be granted.
We will see
GEORGE SHARP: "It is important to understand that this is not a rejection by the FDA for Radiogel treatment on humans. The future for $RDGL is still bright. Radiogel just does not meet the criteria for fast tracking under the following criteria"
It would make sense....the FDA wouldn't just say no they would more so advise that this is suited for another program especially if one was just on the Horizon like the Safer Technologies Program.
Also the review time and entry application could be waived altogether.
Everything seems to connected to be a coincidence, especially when they left their tweet open ended with "big positive" and "benefited us considerably"
And using "faith is taking the first STEP" in their Friday tweet.......too many cryptic stuff
Better than nothing!
Look at their Friday tweet "step" in the right direction
....my goodness the clues if I'm right
STILL BEING FAST TRACKED VIA STeP
WE ARE GOOD HERE!
I JUST DID SOME DIGGING!!!!!
So in the tweet on the picture
It says "we are disappointed to learn FDA did not gran option device BUT criterion 2a was met as a breakthrough technology"
THEREFORE
If you read on FDA if you do not obtain IDE but still qualify for another criterion
"ARE THERE RELATED PRPGRAMS DESIGNED TO EXPEDITE THE AVAILABILITY OF CERTAIN DEVICES THAT MIGHT APPLY TO MY DEVICE"
There is a "safer technologies program" which is what our criterion 2a is
Check out FDA STeP
Directly for Devices and device led combination products (which we are)
Now there are more criteria
1. Not eligible for BDD (which we just met)
2. D) an improvement in the safety of another device or intervention
I BELIEVE WE ARE GOING FOR STeP
Ya I just wish it climbed on longs and not these dimwitted flippers who jump in and jump out......wed be stable and still eying the delayed take off date of June
Not laugh?
Why are u happy about this?
They said in previous PR they want to obtain IDE which is possible by 2nd quarter....June.
So in longs eyes we are still golden but this will take a hit tomorrow at open from all the last minute buyers that jumped in for an instant boost.
I like this board lol
Let's all just put the guns down nice and easy now.......everyone's had enough to drink these last couple days / weeks.
Nice and eassssy.....
No problemo
Also....U wouldn't want seeds in your brain or lungs now would you?
Radiogel has very slim limits.....and by the spleen experiment at Mayo its evident that no leakage is a major benefit....completely localized....no foreign objects....One and done bye bye tumor
Cesium 131 has nothing to do with us....Y90 yttrium is where its at.
Y90 is already approved in itself.
We do not use seeds we use a gel.
Gel breaks down, easier to distribute.
We have the only device that delivers Y90 in this way.
CESIUM 131 CAN SUCK IT
Oh I totally put a comma in your sentence that wasn't there......Commas make a world of a difference
For instance
Let's eat Grandma!
Let's eat, Grandma!
Two veerrrry different sentences
...Don't judge me
Welcome to the back of the class
Lmfaooooo!
Looks like we are the two sitting at the back of the class just sliding by haha.
10-4 ....Regardless we are golden IMO
Tomorrow will be interesting
I totally read this wrong .....I thought u were saying a source told u we got approval.
*Looks at watch
*Looks at calendar
*Looks at both two more times
*Does nothing productive
*Checks everything one more time
$%#@$!
*goes back to bed
Even better!
MANNNN!!!!! .....pinky swear?
Same....still a possibility they don't even know yet or haven't heard back......at this point noone knows but we will find out soon. Feelings are positive though
Your broker isn't updated.
There were no T trades either so closing was $0.25.
Or they are stealing your shares! Lol stop them!
No for real though set them at a High sell price so they are locked from your broker borrowing
I hope you are right my friend....would be a glorious PR
There technically isn't a deadline .....especially with Covid some things may be delayed. 60 days is standard protocol but these days anything goes so I mean they may need an extra week given all the BS they're going through. Noone really knows
Korenko loves being clever I'll tell u that much for free
I don't think it was a real signal lol ....but I mean if they were dropped as a real signal they were all buys.... so it would be good news.....time will tell
Wall down!
I hold no judgment! Haha
Lol your autocorrect though.....we all know what uve been searching now hahahaha
Haha sorry to hear! Last minute sale though! ...should be a green close after this massive fake wall gets taken down
Solid bid support is in
MMs looked like they needed to refill and by the looks of L2 they just did.. should work its way back up
See...its like magic
I've give you a clue....this happens everyday lol