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I hope we hear something tomorrow!!!
I think it's possible, but this is the FDA, so very unlikely, they'll probably have to do some more tests but definitely not a clinical trial
Here it is, from the call
"Third, SequestOx. Adjacently the requirements are underway. On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different ole, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, we are at BE, but first we need FDA’s feedback and blessing."
They already did it....COUCH, you have a link to where Nasrst mentions the tests they completed for the TMax? I'm at work and can rifle through the posts to find it
From the lab, I can't remember in which PR it was stated that they ran several fatty, oily etc... tests to eliminate the TMax issue and they were waiting for the FDA meeting (which happened in 12/22/16) to see if that was sufficient.... which is what I believe will be the meat and potatoes of the next PR end of this month.
Page 3,
"Sponsors may wish to use relevant principles described in the guidance for industry on
SUPAC-IR: Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR guidance) to determine if in vivo BE studies are recommended. These BE studies, if indicated, should generally be conducted under fasting conditions."
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf
It's not a clinical trial, it's a separate data set, give me a few minutes I will provide the link to FDA guidelines for such studies.
They are conducting in vitro studies which doesn't involve people, it's a study executed in a controlled environment like a lab.... they're not required to do an in vivo study, or the kind that requires people
SMAA--Looks like news is on its way!!!
Depends on the news, don't forget, only $5 million will send this to .01.... with the sector they're in that's just a stones throw away... there is good news and there is GREAT NEWS
SMAA---more of their products
http://windstax.com/about/
SMAA --- their products aren't cheap either!! High quality!! High demand!!
https://www.flauntvehicles.com/
There products are the real deal!!
https://www.flauntvehicles.com/
I may do the same to withdraw my original investment but she's going to go a lot higher than that
I'm not selling till pennyland!!
They also have an automotive sector as well as wind/solar for home/business ...only going up here with such a small float!!!
Already 50 times the average volume!!
Already 50 times the average volume!!!!
SMAA---Here we go!!!
SMAA---especially with this float!! Not many holders will have .0002s in their accounts, almost whole ask eaten up in 2 days
Anybody have a level two snapshot?
SMAA--Less than 100 million shares left at these prices
SMAA---- don't miss the run, getting ready to gap up
The 23rd is 30 days, then they need a few days to put a PR together ( if they haven't already) I expect the PR to be released on the 30th. Just speculation of course.
Well argued weezuhl, posts like this I respect, regardless of connotation... real information one can use for their advantage, not hollow fluff
When it runs this time it will run much higher, lot of people still holding old shares and the float is lower... at least .002-.003
RXII already +2million volume ... seems like the acquisition was a solid move but that news was a few days ago, something is driving it
What's going on with RXII? Up almost 40% premarket....thinking about exiting but there's no news yet
That would be a bad move on the company's part even if it was good news, you want to release good news early in the week giving people a chance to buy up all the news just hot and bad news at the end of the week so the long weekend will help them forget
I was in this company about six or seven years ago, I think I tripled or quadrupled up back then... I might throw a couple hundred bucks in here free money is free money
That's when I pull out my initial investment and ride the freebies
$38? Of course not!! I can see an argument for $3.80 but definitely not $38.... unless we get approval LOL
It showed back up on E*TRADE ...funny
With this potential in this company, considering approval/andas/current generics etc.......how is a swing in price ~5% up or down even a topic for discussion ??? We ran +15% last week, maybe -5% this week.... who knows what next week holds? It's the OTC market.... nothing will be concrete without company PR, sit back, wait, and MAKE MONEY when it presents itself
Only 2.3 bil outstanding......bid count keeps rising, they want shares..... grab these 2s this will run, not sure how much I predict between .002-.003, but they have products, good products...
I like the float here, a little news and she's a runner, maybe .002-.003
I'm almost capped at a 10% position, I'm a buyer at around .153, I hate buying odd numbered shares lol
They just shook the hell out of those stop losses and re-raised the bid.... that's why I don't use them in sure plays...
It has disappeared off of E*TRADE, has trading halted?
They want to be on NASDQ before release of top line results sometime in April... according to CEO, who I think is an idiot because if top line results are good they can get there without R/S