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Morgan Stanley New APPY shareholder just out bought 349,801 shares & next week we will see all the updated Institutional holders
http://www.nasdaq.com/symbol/appy/institutional-holdings
Morgan Stanley New APPY shareholder just out bought 349,801 shares & next week we will see all the updated Institutional holders
http://www.nasdaq.com/symbol/appy/institutional-holdings
APPY agreed digesting 35% move nicely after finally breaking resistance at $1.40 & went to $1.60's now $1.40 has become support. Setting up for next leg up & next weeks conference maybe the catalyst needed.. GLTA & make $$$$$$$$$$$$$$
APPY news out CEO presenting @ Canaccord Genuity growth conference next week... No doubt CEO will be asked for updated enrollment #'s & I'm sure they are good or they wouldn't be presenting & should be a nice catalyst next week....
http://finance.yahoo.com/news/venaxis-present-canaccord-genuity-33rd-145900201.html
O.T. The biggest mistake I see young traders make is entering a full position in one shot or 1 day.... NO one can call a perfect top or bottom so first allocate a proper % of your portfolio that you want to own of a stock ( No Texas Holdum All In's ) then buy 20% of that full position you desire, be patient do DD, check message boards, filings & most importantly spend a few days seeing how it trades, add in small pieces over weeks not minutes. The stock may start rising but I would rather avg up then down. Once in a full position use proper discipline of 8 to 10% drop from your completed avg price = sell no excuses... If the story changes for the worse regardless sell ASAP.... You must always use good discipline to protect your capital without $$$ = no tools to make money.....By utilizing these & other strong disciplines it takes the emotion out of trading & allows for clear thoughts. On winners let them run & use a trailing stop as the shares keep rising move your stop up....Hope this helps & remember every day we get new opportunities so getting trapped & refusing to take losses is a poor choice & waste of valuable money making time....GLTA & make $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
New S/A article out on APPY after hours link
http://seekingalpha.com/article/1581732-venaxis-well-funded-ahead-of-multiple-catalysts-expected-through-year-end?source=yahoo
APPY new S/A article out after hours Link..
http://seekingalpha.com/article/1581732-venaxis-well-funded-ahead-of-multiple-catalysts-expected-through-year-end?source=yahoo
APPY nice high vol breakout $1.50's
APPY Street article popping it $1.44 HOD
APPY New Street article 13 stocks setting up to spike higher link as APPY on page #1...........link
http://www.thestreet.com/story/11991001/1/13-stocks-under-10-setting-up-to-spike-higher.html?puc=yahoo&cm_ven=YAHOO
APPY new street dot com article out mentions APPY link
http://www.thestreet.com/story/11990459/2/4-health-care-stocks-under-10-to-watch.html
In listening to last CC CEO stated that enrollment is accelerating & at 28 sites looking for 3 to 4 tests a week per site. If this ramp up is defined in upcoming call & #'s come in at 250+ per month s/b a share price mover imo....Either way at these price levels sitting near cash on hand & FDA news months away is a great low risk / high reward setup I like ..... GLTA & make $$$$$$$$$$$$$$$$$$$$$$$
$1.40's on vol & plowing right into the $1.75 to $2.00 range quickly & penny flippers will be left behind scratching their little heads lol.....
APPY wont have earnings or rev's BUT imo CEO hinted already ramp up of enrollment in current trial & if #'s ramping as indicated will spike share price nicely imo.....
APPY nice break of 50 day M/A & near term catalysts trading just above cash value
APPY nice vol & price action hope some picked up cheap shares last week..... Also keep in mind early August earnings out & imo will see accelerated enrollment that CEO hinted at on last CC...will certainly spike the share price on that update...Either way small float & trading just above cash in the bank with FDA approval months away....
From CC July 15th has 830 already enrolled ... From CEO q&a...
Just to go back, we got, as I mentioned, about 830 patients that are enrolled now. So we've got approximately 400 to go. And at a rate of -- accelerate above the 200 a month we're doing today and look at a follow-up of, say, 3 weeks after that to get all the database closed, so that's probably -- we're looking at 2 months from now or so.
http://seekingalpha.com/article/1550572-venaxis-ceo-hosts-second-quarter-2013-business-update-conference-transcript?page=5&p=qanda&l=last
Agreed typically but being a high margin test & APPY's management team with a history of cautious cash use leads me to believe what CEO stated on conference call this A.M.
APPY CC over quick points covered over 800 enrolled in testing completed & approx. 200 per month being enrolled ...expects by Sept to have all 1200 enrollees tested & results before years end. Cash burn approx. 1 million per month & APPY has 20 million in cash so a little over 1.5 years of cash. Also doesn't take into consideration sales ramp starting in early 2014 which would obviously slow the cash burn even further
APPY CC over quick points covered over 800 enrolled in testing completed & approx. 200 per month being enrolled ...expects by Sept to have all 1200 enrollees tested & results before years end. Cash burn approx. 1 million per month & APPY has 20 million in cash so a little over 1.5 years of cash. Also doesn't take into consideration sales ramp starting in early 2014 which would obviously slow the cash burn even further....
APPY thanks for confirming trial results in 4th Qtr & FDA application in 1st Qtr as confirmed by this a.m. s PR lol smart $$$ would be accumulating not selling imo.....
APPY post from Natty Greene The test is also being evaluated in a pivotal clinical study in the United States, which is expected to conclude in Q4 2013.
The breakthrough diagnostic test has already been granted marketing approval (CE Mark) in Europe where a launch in multiple countries (U.K., Germany, Italy, France, Turkey, Netherlands) is currently underway. In the U.S., Venaxis is currently conducting a 2,000 patient, pivotal Phase 3 study with results expected in Q4 2013.
CEO interview .... We are actively enrolling patients into the pivotal study, which we expect to support regulatory submission for potential FDA clearance of the APPY1 Test System. The first hospital sites began enrolling patients earlier this year and enrollment has continued to ramp nicely as we continue to bring more of our participating sites on line. The study will enroll 2,000 evaluable patients in total and we expect to complete enrollment and report top-line data by the end of the year. We plan to submit our 510(k) package to the FDA as soon as possible
APPY Sheff please tell where you obtained your August trial timeline as I cant seem to find it anywhere Thanks in advance $$$$$$$$$$$$ All I can find is the co. timeline that trial & results by Years end thanks again Pmony....
APPY $1.32 close on almost 2.1 mill vol & CC in A.M. s/b interesting as imo many were using incorrect info to base their investment in APPY & smart money loading on the cheap will do very very well in the weeks ahead GLTA & make $$$$$$$$$$$$$$$$$$$
Seems some thought results from trial would be out sooner then years end but I have always believed what the CEO & co. stated that by years end trial & results would be presented .... Todays PR leads me to believe that trial will be done by years end but results a few weeks out & FDA application which ALWAYS was to made in 1st Qtr 2014 will still be ... So imo worst case scenario a few weeks behind ... APPY a 25 million dollar market cap co. with over 20 million in cash & European approval with FDA U.S. approval so close entering a 200 to 500 Mill $$$ market is insanely cheap & perhaps the best risk/reward bio out there right now..... Want to hear CC in the A.M. before adding another 50K on the cheap.... GLTA & make $$$$$$$$$$$$$$$$$$$$$$$$$$$$
Agreed APPY has always maintained trial & results by years end ... not sure where new earlier dates came from perhaps some of the new shorts lol... GLTA & make $$$$$$$$$$$
CEO stating in interview....
The study will enroll 2,000 evaluable patients in total and we expect to complete enrollment and report top-line data by the end of the year. We plan to submit our 510(k) package to the FDA as soon as possible
http://seekingalpha.com/article/1522902-exclusive-interview-with-stephen-lundy-venaxis-president-and-ceo?source=yahoo
APPY Not sure where delay talk comes from CEO stated We are actively enrolling patients into the pivotal study, which we expect to support regulatory submission for potential FDA clearance of the APPY1 Test System. The first hospital sites began enrolling patients earlier this year and enrollment has continued to ramp nicely as we continue to bring more of our participating sites on line. The study will enroll 2,000 evaluable patients in total and we expect to complete enrollment and report top-line data by the end of the year. We plan to submit our 510(k) package to the FDA as soon as possible,
http://seekingalpha.com/article/1522902-exclusive-interview-with-stephen-lundy-venaxis-president-and-ceo?source=yahoo
Looks like headed back up as fast dumb money leaving... with a 25 mill $$$ market cap & over 20 million in Cash = great risk/reward setup..... BTW also of note Institutional ownership rising quickly & will gladly stay patient GLTA & make $$$$$$$$$$$$$$
APPY according to CEO interview always was end of year LINK either way talking weeks for a pre market cap of 25 million dollars & over 20 million in cash entering a 200 to 700 million dollar market next year seems nuts to sell so cheap as I'm a buyer on weakness this a.m.
http://seekingalpha.com/article/1522902-exclusive-interview-with-stephen-lundy-venaxis-president-and-ceo?source=yahoo
APPY 8K filing out CASTLE ROCK, Colo., July 15, 2013 — Venaxis, Inc. (Nasdaq: APPY ), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY 1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY 1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.
The futility analysis, which consisted of an independent review of the validity, integrity, and clinical and scientific relevance of the ongoing study, was performed on the first 579 patients to complete the study. The study will enroll a total of 2,000 evaluable patients. The next and final futility analysis will include data from the first approximately 1,200 patients.
Steve Lundy, President and CEO of Venaxis, stated, “While the results of the study remain blinded to Venaxis, we are very pleased that the pivotal clinical trial has passed this important interim analysis step successfully. The APPY 1 Test performed very well in the previous 500-patient study, so we regard this outcome as encouraging and we look forward to the next assessment. Enrollment in the pivotal study continues to accelerate as our recently initiated sites ramp-up their enrollment. We expect to complete enrollment for the pivotal study by the end of 2013, and if the results are positive, file for FDA clearance in the first quarter 2014. In the meantime, we continue to execute on our commercial milestones in Europe, where we are preparing to initiate economic outcomes studies at leading hospitals. Importantly, with our recent financing, we have sufficient capital to achieve major regulatory and commercial milestones. While we remain prudent with the use of cash, we see no financial obstacles to reaching these significant value inflection points.”
Venaxis strengthened its financial position with an additional $14.4 million in gross proceeds from a May public offering led by Piper Jaffray & Company. The Company currently estimates cash, cash equivalents, and short-term investments to be approximately $20 million at the close of the second quarter 2013, which will be reflected in the Company’s Form 10-Q to be filed in the coming weeks.
Don Hurd, Senior Vice President and Chief Commercial Officer of Venaxis, stated, “We remain on track for a full-scale European launch for the APPY 1 Test beginning in the fourth quarter of this year. We currently have four market development agreements in place and we are in the final process of selecting partners in additional target countries, including Germany, the UK, and France. In terms of our existing partner agreements, we are initiating and expect to complete several outcome studies by the end of the third quarter 2013 and anticipate leveraging robust data from those studies to demonstrate objectively the clinical and economic value of using the APPY 1 Test in the hospital emergency room. We remain focused on laying a solid foundation as we continue onto full-scale commercialization of APPY 1 in Europe and advance to commercialization in the United States.”
Conference Call Information
The Company has scheduled its quarterly conference call and webcast for tomorrow, July 16, 2013, at 8:30 a.m. ET. Interested participants and investors may access the conference call by dialing 1-800-860-2442 (U.S.), 1-866-605-3852 (Canada) or 1-412-858-4600 (international). A live audio webcast will be accessible via the Investor Relations section of the Venaxis web site, ir.venaxis.com .
A telephonic replay of the call will be available for 30 days beginning at 10:30 a.m. ET on July 16, 2013. Access numbers for this replay are 1-877-344-7529 (U.S./Canada) and 1-412-317-0088 (international); conference ID: 10031489. The webcast replay will remain available in the Investors Relations section of the Venaxis web site for 90 days.
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001079973-13-000449.txt&FilePath=\2013\07\15\&CoName=VENAXIS%2C+INC.&FormType=8-K&RcvdDate=7%2F15%2F2013&pdf=
APPY nice read & following huge % increases in Institutional buyers has always been great recipe for making $$$ as long as you got in early... Trading just above cash in the bank & a $7.00 Analyst target with near term catalysts = a very low risk & high reward stock setup my fav.GLTA & make $$$$$$$$$$$$$$
APPY new S/A artice Natty Greene link..
http://seekingalpha.com/article/1544122-institutions-increase-ownership-in-venaxis?source=yahoo
APPY nice Bob ty goes with last Qtr 1.7 million in new Buys & 44k in sells link. 20 million shares out & 3rd Qtr catalysts plus Market Cap sitting near cash levels.
http://www.nasdaq.com/symbol/appy/institutional-holdings
APPY working off an overbought condition about 5% off recent highs..
APPY agreed Sheff due for .20 to .30 up day as vol has been strong & getting more & more attn....GLTA & make $$$$$$$$
CYTK any bio experts please opine how to take todays news....short & longer term effects thanks so much....
APPY nice continuation from board $1.20 alert near term catalyst & no dilution fears with over 20 million in cash... CEO stated enough cash to get through FDA approval & commercial launch. Also keep in mind APPY has only 20 million shares outstanding so a very tiny market cap here & imo undervalued GLTA & make $$$$$$$$$$$
APPY appears to be breaking out of Month long basing in $1.20's on nice vol.... Bodes well for continued move back to higher ground before financing..BTW here is link to Institutional ownership
http://www.nasdaq.com/symbol/appy/institutional-holdings
APPY been basing for a month & trading just above Cash with 3rd Qtr Catalyst & recent history above $2 a share. Also note Institutional ownership all new positions last Qtr 1.7 million in buys & 44K in sells
APPY chart sure looks ripe for quick move to $1.60 to $1.70 area on break of $1.30's