Trust me, trust no one.
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Please provide a link or any level of substantiation to this 'rumor', I certainly wouldn't mind that being true but I'd also like to see it go way above three cents!
Sell orders.. bad voice translate
If everyone simply puts in cell orders for $10, it locks your shares and they cannot be borrowed too short. If enough people do this it reduces the ability to manipulate
I don't think so, while he would probably try to find illegal (real not state sanctioned illegal) fronts he simply doesn't have the resources to go after the public. First off he will encounter a huge legal battle, lawsuits which judges have more and more often found in favor of the dispensaries, and second he would instantly damage his ability to get more important things done.
No one seems to note the under Obamas administration there were plenty of raids and attacks and the industry continued to thrive.
He would get gimped, his budget lowered, lose resources and create a battle with the American public and the demand would keep growing. That demand would get filled with illegal weed. So he would basically end up spending taxpayer money to help the cartels. Just not going to happen.
He will probably attack some specific places if they believe it is an illegal operation (Beyond the states laws) and out of the ones he raid will probably mess a couple up. Otherwise of that the industry will march forward.
Everything boils down to economics, and the amount of money has become too great to ignore.
The schedule 1 issue sucks but as I understand some archaic laws make it an international issue and not as easy to change it as one would like.
Cheers
I don't think so, while he would probably try to find illegal (real not state sanctioned illegal) fronts he simply doesn't have the resources to go after the public. First off he will encounter a huge legal battle, lawsuits which judges have more and more often found in favor of the dispensaries, and second he would instantly damage his ability to get more important things done.
No one seems to note the under Obamas administration there were plenty of raids and attacks and the industry continued to thrive.
He would get gimped, his budget lowered, lose resources and create a battle with the American public and the demand would keep growing. That demand would get filled with illegal weed. So he would basically end up spending taxpayer money to help the cartels. Just not going to happen.
He will probably attack some specific places if they believe it is an illegal operation (Beyond the states laws) and out of the ones he raid will probably mess a couple up. Otherwise of that the industry will march forward.
Everything boils down to economics, and the amount of money has become too great to ignore.
The schedule 1 issue sucks but as I understand some archaic laws make it an international issue and not as easy to change it as one would like.
Cheers
Grabbed another 1.9 mil shares at
0.0019, why not? We see where this goes...
Hint the 'Caps lock' button is on the left side of your keyboard. You might want to press it.
Oops I meant 12600...
I'll go ahead an take advantage if the cheap prices then. Grabbed 12700 at .16. ~410k shares now. Hmm maybe I need to get a few more to have 420 :p
Go NRTI
Still mind boggling why anyone would sell right now. 1 week, with the news everyone has been waiting for... If you are buying in the penny stock world, but can't wait a week? I guess they need the money to buy lottery scratchers.
It's simply baffling why anyone is selling now. (Outside the manipulation attempts) everything we have been waiting for is coming to fruition, and in about 2 weeks we will finally have the hard data to back it all up. The company has done so well in such a short period of time, executed flawlessly, hired intelligently, and managed cash with superior skill and strategy. If you can't manage to wait 2 weeks, go to Las Vegas or go okay poker online, because you are a gambler and not an investor. (No offense poker players, as that's actually a skilled game too. :p )
I picked up another 9k shares, such a steal at this price. Just broke over 400k shares!
Well if they have to they have to. I just said ideally. I don't know what communications they have had so far with the FDA, but it's entirely possible CBER said class III and PMA. I was simply hoping they could negotiate into a Class II and go the 510(k) route. I know that's what I would push for.
Ideally this won't matter. They should be able to go through the 510(k) process as a class II and avoid a PMA. Yes the could very well end up PMA if the FDA decides it's a Class III, but seems they should be able to find a 'substantially equivalent' (in terms of safety and filtration as a primary mode of action) cleared medical device in the 510(k) database.
It would generally decrease time and costs, though they would need to complete a registered clinical trial.
Once submitted it should take 6-9 months to clear. Though as stated before CBER would probably handle this 510(k) and not CDRH so that could make things more difficult as they are notoriously more difficult to work with
13 Sell trades of 550 each in a row. More blatant attacking on the PPS to bring it down, which looks like was successful for the moment, moved us from green to red. Such crap.
And thank you CN for getting me out unscathed as well! The 87k shares I bought in NRTI already paying off and will be a nice payday in just a few weeks on Q1 results. I'll use the profits to buy a few more CSTO as well.
So what happens if each of us buys 1 share at the ask? I'd be game for a $10 experiment to see how that affect it, just take turns buying 1 share at the ask!
It's just baffling to me how PPS is calculated that one .17 transaction (and x50 in transaction fees) out of ~60 million outstanding shares can move the needle at all. One would think this blatant ability to manipulated would be outlawed or force a change in algorithm at a minimum
Lol I'm not freaked out about fatherhood too much, I'm blessed with a great wife to support and a healthy daughter. I know I'll have plenty of extremely challenging times for sure though.
I will however smack the guy in the face with a dirty diaper who keeps trading 1 share if I ever get the chance!
Go NRTI!
Jeez look at those last minute sales. 3 sells of 5 shares each to try to drop the price. Just total BS and a complete joke. Certainly a broken system that even lets this happen and actually affect the price. Didn't work today at least, F those MFs.
Why anyone would be selling right now is beyond me. Just a few weeks from what will be amazing earnings. If you don't have that much patience go to Las Vegas and stay out of investing...
'It can only lead one to surmise that this someone must have other motives in mind. '
Probably the same people who sold 1 share earlier in a pathetic attempt to bring the price down. 1 share... What a joke.
Ok final grab on these low prices. Another 10820 shares at .155. Tapped again on extra cash for now. So just sit back and wait for good news.
394500 Shares now, looking long for a payday. As of 3 weeks ago I've got a new mouth to feed so trying to pay for her college 18 years early!!! :p
Go NRTI
Heck I still couldn't help it put in for another 36000 but only got close to 17000 before the close!!!
I certainly am taking advantage , just picked up another 32000 shares at .15!
Go NRTI
'the recent decline in SP is mainly due to the fact that the figures have shown that Martha Stewart is proven not to be the cash cow she was supposed to be.'
This is a ridiculous statement. This partnership, production and distribution has just gotten started. Q1 results haven't been posted. If the same numbers occurred for the next 5-8 quarters then you could make such a statement. Their is no way you can make a correlation between MS sales and current share price. Apparently you have no understanding of the product development, operations scale and distribution process.
The 'Intended Use Statement' is a driver in the 510(k) process for determining substantial equivalence. But to prove safety, it doesn't necessarily mean you have to have another cytokine filter to compared it to. You (most likely, again the FDA is it's own beast with individuals who have differing opinions) need to prove the primary mode of action is equivalent. i.e. Blood filtration of a component. FDA thinks in terms of: primary mode of action, e.g. filtration vs chemical bonding vs chemical breakdown etc., power source: battery vs ac in wall, etc and population for which it is proved safe and effective. (e.g. This works for Females aged 8-18)
Many companies will have a new product that no one else has done, but the primary mode of action will be equivalent enough. in this case blood filtration for a component. I've seen plenty of comparisons in products that seem completely different but the primary mode of action is close enough.
btw: the 'Intended use statement' is an important aspect of any medical device. Not to be confused with the 'indications for use'
Typically the Intended use is higher level 'This product filters cytokines from the blood' and the 'Indications for use' is the subpopulation the device has validation data. 'This product is for females aged 5-50' (there is a little more to it than that but in general)
For the 510(k)s ive done, typically is 6-12 3" binders of data. For perspective, a PMA would be a pick up truck of binders.
I just want to emphasize, a 510(k) on a product such as this, is not a slam dunk nor simple. They already have a lot of data though for their CE marking which should be able to be use in the 510(k) submission. Plus they should already have an ISO13485 accredited QMS (Quality Management System) in place. These will go a long way for data to go into the submission.
Ok, I got to get to my own job and dealing with my own regulatory issues. :)
Sorry i can only post 3 times a day with my free ihub account.
I've got a small position only been here a few weeks. I learned about the stock through Crookedneck. I am looking to add more when I have cash freed up. I never carry more than a couple penny stocks at a time so this and NRTI are it for now.
I would certainly never say '510(k)s' are simple. In fact in many ways they can be more nerve wracking than PMAs.
While PMAs are typically longer and have more requirements the process is 'on rails' PMAs can be more predictable which investors like. Because less guidelines in a 510(k) process around what is required to prove safety and efficacy 510(k) clearance can have many more point battles and variability it in timeline. I can't state how it would affect investors, what would probably be the most negative is if they went 510(k) but were forced into a PMA. Starting out on the PMA path might not be the worst. (100% opinion, and only a educated guess at that)
Remember the 510(k) process is a 'substantial equivalence' process. You are proving your device is equivalent enough to a device already cleared in the 510(k) database it terms of safety. You still have to do all the bench testing, verification and validation and clinical trial (not for every medical device but in this case I'm sure it will be needed) as part of the submission package.
Let's think why this would be a PMA. The FDA might call it class III due to the fact this is directly going into the blood, therefore if their was a contaminant a patient could get hurt easily and they deem the risk high enough. Another reason would be: nothing to compare it to in the 510(k) database. I don't think so though unless they state the filtration technology is so divergent from other filters it is not comparable.
My opinion is still a class II and a 510(k) through CBER. So 9-12 months once submitted.
If we lucky 510(k) through CDRH and 6-9 months.
Reminder:
510(k)s are 'cleared'
PMAs are 'approved'
(Us Regulatory types have to correct folks all the time, especially marketing but it's an important distinction.)
Just my opinion, but it should be a Class II medical device and go through a traditional 510(k) process. There are many filters already cleared in the 510(k) database they could use for substantial equivalence. (The 510(k) process is purely about public safety and efficacy so as long as the primary mode I.e. Filtration is in the same league as other filters they should be able to compare)
PMAs are for drugs and class III medical devices. Medical devices that don't have a predicate device to be compared to are bumped automatically to Class III even if they end result is a class I or II. (There is still a workaround called a 'de novo' 510(k) but I won't get into that)
PMA (pre market approval) is an 'approval' process takes a few years and a couple million dollars. They are a major deal and most medical devices will avoid this route. I really do not think they need this.
510(k) is 6-12 months and about $250k (when all said and done, actual submissions fees are only a few thousand)
For perspective: The number of 510(k) s cleared in a year is usually about 3000, the number if PMAs is only about 20.
My main concerned cited earlier is having to go through CBER vs CDRH. CBER is a pain to deal with and asks for a lot more data and are not efficient at all.
Again my opinion. I am a director of Regulatory affairs and QA in medical device / clinical in Silicon Valley. I work in genomics / Next Generation Sequencing if that helps boost my opinion. :p
Although it might take 9-12+ months for FDA clearance if they have to go through the CBER branch for 510(k) clearance and not the CDRH branch of the FDA (FDA has 3 branches for the drug/device process, CDER - Drugs, CBER - Biologics and Blood, CDRH - Device) because the input and output material is blood, CBER would probably review the 510(k) submitted. Unfortunately, CBER is notoriously difficult to deal with compared to CDRH.
The FDA absolutely does not validate your clinical data. They review the data submitted as part of the medical device clearance process.
This is a medical device and not a drug. Therefore it would go through the '510(k)' process. This process is used to prove 'substantial equivalence' in terms of safety to a predicate device that has already been cleared ('cleared' not 'approved') for marketing in the USA. Medical Devices are 'cleared', Drugs are 'approved' and there is a big difference in the process they go through. (You cannot state 'FDA approved' on a medical device, it's FDA 'cleared' for marketing)
For CSTO I imagine they would use another filter already cleared by the FDA on the market as the predicate device.
Once CSTO has completed all testing and submitted their 510k to the FDA, it should take about 6-9 months to receive clearance. After which they can begin selling in the USA.
I don't think the team he has built is unreasonable. Developing a health / medical product is not a simple thing. Mr. James has been smart with money and strategy so far. There are always significant research costs in a start up. As long as they remain focused and execute, it will be great for all.
He understands cash flow and that is key for a start up environment. Otherwise once you are out you are done. Unethical types will screw the shareholders sometimes while the ship is going down, but I really don't think this is the case here one bit.
I personally like the 'completed the group' so we know a) we have everyone needed to commercialize a product (ie Mr James has a product development plan and has resourced it appropriately) and b) we can expect things to move along now ie execute
Therefore no red flags at all. Just moving along. Just my $.02
The shares are still on the cheap... Hit the ask, hit the ask. Squabbling on a penny or two is moot!
Ok CN thanks, i followed you and sold my shares. Didn't lose anything so no harm no foul. More importantly I used the money to buy more shares if NRTI!
Such low prices, could not help myself so I grabbed another 27k shares at .169 and .17.
334000 shares, go NRTI!
Thanks CN. I love they are distributing through Pricesmart. I own this stock, just think International Costco. I also own Walgreens which has been very solid. Just noting these are both very well run retail companies, and not so easy to get into especially for small players. (Not small for long :p ) It's simply incredible the channels Mr. James has for NRTI in so short of period of time. Just exciting times and NRTI is going places soon, no brainer here.
Go NRTI
We already have! ;) Now it's round 2!!! :p
Bought 60k a few weeks back. But very quiet since, is there anticipated news so a waiting game for now? I'm in no rush, I know these things take time.
You think a chance of the Q1 results coming in before May 15th? If not that would be nice to have some announcement between now and then. Very exciting times!
Seriously? You even understand how much was accomplished last year to get all this set up without additional funds? (via dilution) real companies take some time...
That's more like it! I wonder what the rules (if any) are for having to list a ticker symbol when mentioning a company name in a financial report. E.g. They list TRTC of course but not Walgreens or Pricesmart (I own both of those long a few years, been awesome longs) just curious anyone knows. If they had WAL and PSMT and then the article posts to their news info seems like great PR. I'll assume no special rule otherwise everyone would figure out a way to mention other companies. Just curious though.
http://ih.advfn.com/p.php?pid=nmona&article=61654908&xref=newsalert