Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
On your next video maybe you can cover IMUC.
I love to see the strong buying in this .25 to .265 range. It really looks like people are loading up. When we get some strong news this thing is going to run hard.
Since May first there have been just over 1 Million shares that have sold in the .25 to .265 range. That is about $250k in dollar volume. Someone is loading up and being careful to not push it up as they are buying.
I just might have to buy some more....
Nice move today
NAVB Wow!
NAVB just got out at $1.90 for a >17% gain... Boy did I need that!
Thanks for the tip on this one KEI!
Yeah I am still holding....
NAVB $1.72 and the chart looks great here. Back to the $1.90s next week?
Looks good here, someone has been buying for over a month. They must have over a million shares by now. I really think this thing will move once FDA meeting news comes out.
From today's (6-3) Filing:
We believe that in order to file a NDA for Lung-ARS with the FDA, we will need to demonstrate efficacy in animal models and demonstrate product safety. We also plan to request Fast Track status for this indication. If the FDA accepts our Fast Track request, a rolling NDA submission process is enabled, a key step in achieving Priority Review. The FDA determines within 45 days of a company’s request, made once the complete NDA is submitted, whether a Priority or Standard Review designation will be assigned. The Company plans to file the Lung ARS IND and Fast Track Request during the first half of 2014.
The FDA’s “Animal Rule” enumerates criteria whereby the FDA can rely on animal efficacy data when evidence is needed to demonstrate efficacy of new drugs against lethal or permanently disabling toxic substances when efficacy studies in humans cannot be ethically conducted. The criteria are as follows:
· Knowledge of the mechanism of radiation-induced damage to the lung and its amelioration by the candidate drug.
· Pharmacokinetic and pharmacodynamic analysis to provide information on relevant dose and administration schedule.
· Direct correlation of key study parameters (e.g., survival or major morbidity) with the desired clinical benefit in humans.
· Collection of efficacy data in two species relevant to the human radiation response and its treatment unless otherwise justified under GLP-compliant conditions.
· A Phase I safety trial using the same product and formulation as used in the pivotal trial(s) is required.
Demonstrate Efficacy in Animal Models
Under the BARDA contract, we have developed and validated mouse and NHP models for Lung-ARS. We have also presented these models to the FDA and they have concurred with our design and our development plan for demonstrating efficacy. We believe that the efficacy data produced in pivotal studies using validated models will provide the data required to demonstrate efficacy of 10150 at the dose and schedule proposed for licensure. A second criterion of the “Animal Rule” is that the models must be reflective of “real world” conditions to which a human is likely to be exposed. Our models have been designed to reflect these real world conditions.
Huge break at .25 there. Next step .30
I hope they give an update on the NDA during their talk.
NAVB very nice.
NAVB: I took a starter position today...
The chart is looking good here. It is just a matter of time until we bust through .25 and move on up. tick tock...
Somebody got a nice chunk this morning at .01. Nice buy.
There has been a nice bidder this past week. Waiting....
Small nibble today by somebody. Just got to wait this one out....
Yeah it is interesting to see the bashers come out like this. There have been some huge bidders the last 5 days buying a lot of shares. They no doubt knew what the earnings were going to be. I think we move north today in a strong way.
Nice volume the last two days.
Maybe we are ready to make a steady climb to $40?
yeah if i knew were the bottom was i would not have bought today. I am just buying some here and there until I get my average down below .50. I think we have several months before it moves north. I just don't want to be caught waiting for teens when it starts to move. Today I lowered my ave from 3.28 to 1.32.
Alright I started averaging down today. My ave is now 1.32. Maybe next week it will sink to the .20s and I can get more.
OT: I feel his pain, I was up about 20k for the year about a month ago. I am trading a small account under 50k. As of right now if I were to liquidate my positions I would be at a net realized gain of about $1k. I feel good about where I am sitting now and am optimistic for the rest of the year. I should say I do not feel good about the IBB or DOW for the next couple months. I want to really see it stabilize before I get back in with normal sized positions.
Wow ADCOM zero vote, glad i was in for only a half position.
One interesting outcome of the early halt is that shorts might not have had a chance to get out. If the news is positive it could really run.
Man I sure hope so. As long as the NDA goes well, which I think it should then we should be good for a nice run into the PDUFA in May.
A trading halt until the 24th! What the heck!
http://www.otcmarkets.com/otciq/ajax/showNewsReleaseDocumentById.pdf?id=131576958
Okay back in for a half position at 3.28. I will keep a tight mental stop on this one...
Well I got out yesterday in the 3.64 range for a small profit. I should have taken the profit at 4.05. Live and learn, I am surprised how quickly it cracked. It might be worth picking up some for the ad com next week.
Man I have been really busy at work... AOLS is looking okay right now. I still want to buy more before I'm done. I'm just trying to get in early before a NDA meeting date is set. It is a bit risky, but the payoff could be very nice.
... back to work for me...
QRXPY yeah I am holding. I am hoping to get out in the $4.30 range. There are two very strong catalyst with this one. I think one of these days we will see a very big green candle.
QRXPY starting to move. It has an NDA on April 22, 2014
and a PDUFA on May 25th 2014 http://www.biopharmcatalyst.com/fda-calendar/
It has been moving north the last several days. Worth watching here.
Here is some DD.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=99906722
Well I picked up another 10k shares today. I only want about 8k more before my buying is done. I can't wait until this starts getting on people's watch lists when the NDA is announced. I expect this will start moving in the next month or less... that's just my guess
Anyone from $heff's board playing this?
Gold is up nicely today. Maybe this will move north.
$APPY offering 8,335,000 shares of its common stock at a price to the public of $2.40 per share
http://ih.advfn.com/p.php?pid=nmona&article=61711857
APPY I totally agree! I think we have some time though, I believe we have 90 days until the 501(k) decision.
APPY Files Shelf down 15%+ after hours, will be looking to buy once the price stabilizes
http://ih.advfn.com/p.php?pid=nmona&article=61700841&symbol=APPY
APPY Files Shelf: Down 15%+ after hours
http://ih.advfn.com/p.php?pid=nmona&article=61700841&symbol=APPY