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BOCX news from yesterday...if you care...
4/20/2004 1:02:00 AM
RICHMOND, British Columbia, Apr 19, 2004 (BUSINESS WIRE) -- BioCurex Inc. (Pink Sheets:BOCX) is pleased to provide a clarification of the FDA classification of its Histo-RECAF(TM) product.
In May 2001, BioCurex submitted an application to the FDA regarding its Histo-RECAF(TM) kit. The submission included data, pictures from stained tissue sections and reports from pathologists who had evaluated the test. It also included the user manual, which was revised and corrected according to the instructions and helpful suggestions from the FDA officer.
The Food and Drug Administration (FDA) subsequently classified BioCurex's Histo-RECAF(TM) as a Class I device under Regulation Number 864.1850(i). Item (b) reads:
-- (b) Classification. Class I (general controls). These devices
are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the
limitations in Sec. 864.9. These devices are also exempt from
the current good manufacturing practice regulations in part
820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec.
820.198, with respect to complaint files.
The FDA has not "approved" the Histo-RECAF product for the diagnosis of cancer. Instead, the FDA has classified Histo-RECAF(TM) as a Class I device (lower cost and time frame) which allows BioCurex to sell the product for use as specified in its manual as follows:
-- Intended Use
-- Histo-RECAF(TM) is a qualitative ligand-binding histochemical
test kit for use as an adjunct to standard light microscopy
staining methods for detection of alphafetoprotein binding on
formalin-fixed, paraffin-embedded tissue sections as an aid in
the identification of breast cancer in breast and axillary
node tissues. Diaminobenzidine is the chromogen used in the
test kit.
Furthermore, the Company directs the pathologist in the Limitations section of that manual as follows:
-- 5) The clinical interpretation of any positive staining or its
absence must be evaluated within the context of clinical
presentation, morphology and other histopathological criteria.
The clinical interpretation of any staining, or its absence
must be complemented by morphological studies and proper
controls as well as other diagnostic tests. Staining is to be
performed in a certified licensed laboratory under the
supervision of a pathologist who is responsible for reviewing
the stained slides and assuring the adequacy of positive and
negative controls.
The pathologist who examines a tissue biopsy under the microscope typically looks for specific abnormalities associated with cancer. These can include invasion of adjacent areas and shape and size of cells. To visualize these features, the cells must be colored with a stain; for example Hematoxylyn & Eosin or the Papanicolau stain used for PAP smears. Histo-RECAF can also assist the pathologist by staining malignant cells. The FDA has placed Histo-RECAF(TM) within the classification name: "STAIN, PAPANICOLAU(ii)", the stain used in PAP smears used for detection of cancer. The Papanicolau stain is not "approved" as a device for "cancer diagnosis" either, but its role as a stain in the diagnosis of cervical cancer is undeniable.
Histo-RECAF(TM), as a Class I device, is intended to assist the pathologist who will still rely on multiple tools and morphological criteria for reaching a final diagnosis.
For more information about the FDA approving process, visit: http://www.fda.gov/cdrh/devadvice/3122.html
About BioCurex:
BioCurex, Inc. is a biotechnology company that is developing products based on patented/proprietary technology in the areas of cancer diagnosis. The technology identifies a cancer marker known as RECAF(TM), which is found on malignant cells from a variety of cancer types but is absent in most normal or benign cells. To read more about the Company, please visit the News section in our web site ( www.biocurex.com).
Note: The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are "forward-looking statements" within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
(i) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?FR=864.1850
(ii) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/ search.cfm?db=LST&ID=79217
(Due to the length of the above URLs, it may be necessary to copy and paste these hyperlinks into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)
SOURCE: BioCurex, Inc.
BioCurex, Inc.
Ricardo Moro, 604-207-9150
last = OT.../e
TASR gonna fly again../e
COPY back on break watch
I think that .79 first, then .86 will make this interesting again. Few sellers.
I'm in.
A
COPY low vol white candle to near 5dma (.71)..
BOCX error trade at .027 = "error"...
chipped2003 MyTrack shows yesterday's .027 trade as one trade code "z" and "error".
last trades still shows $1.92 from 4/9. Busted portfolios with the .027 should return to 1.92 level tomorrow. Doesn't mean Friday's opening will be anything fun to watch...unless you're into train wrecks or FDA/SEC says never mind, "my bad"..
A.
Capitalist..re: buying power
if your are w/Ameritrade or Freetrade (probably others as well) you can trade unlimited in and out as long as you are trading your own cash and not using margin. Buys then sells refill cash even if your "BP" is eventually empty intraday. You can't do this for short sales however, BP only.
GL
A
BOCX .027 print = code z error message on transaction log...
should be back to 1.92 tomorrow...doesn't mean it won't be painful at the friday open...imo
gl
A
COPY& 50% .../e
COPY holds 5/10dmas
COPY bounced off and held 50% @ .65
bods well for next week if ur still in...
GL
A
DYTK /e
NASDAQ fwiw
Looks like the naz bounced today off the top of the downtrend line drawn from January 26th hi. This may signal a bounce toward higher highs (maybe one more test at 1970s?). If we get back up thru 2080-2100 I'd guess we see 2500-2600 later this year.
all imho and worth about what you paid for it
GL
A
ABIX halted for request of additionalinformation ala BOCX /E
Here goes COPY again..e/
WAVX taking off again.../e
WAVX 39% pop...4 million short /e
ARTX leaving the building /e
ARTX popping /e
PVSS .175 ask = annual High..needs vol. /e
PVSS L2 waking up ../e
otcbb trading halt notice:
http://otcbb.com/marketwatch/
A
I'm stuck in BOCX w/you all ...
they got me good ...here's the pink link:
http://pinksheets.com/quote/quote.jsp?symbol=bocx
A
&BLIZ i see 1k & 4k at 2:12EST on trans log /e
BLIZ 1.46 actual 1.25 must be fat finger trade /e
BOCX threatening to close flat/green...go figure../e
BOCX ...1.75 breaks previous intra day spike../e
BOCX uptrend line from 1.42 LOD should hold for some time, imo, because i think that now BOCX is starting to see some "investors".
If $3.60 ever broken again, upside next resistance target = the stupid level of $6.60. jmho
gl
A
BOCX ...turn estimate at $1.60-1.65ish FWIW /e
Nasdaq nearing HOD... and green close /e
BOCX probably an IRA candidate at these levels../e
$1.82 was 50% of first big day fwiw so it may be good to go after testing and bouncing $1.86
a
BOCX
retracements were:
2.84--broken
2.38--broken..small stall
1.62--next bounce point by the math
1.08--dead
ta bull
bocx is correcting the whole move $0.40 to $3.60 (a wave 1 impulse)...so it is actually a greater degree W2 correction down...
see previous posts..
gl
a
BOCX HOD actually $3.60 yesterday...
not 3.90 ....3.90 was a fat finger 100sh trade. 3.60 actual for chart/computations..
a
BOCX
2.38 = precise .382 retracement of whole move .40 to 3.60
if 2.38 doesnt hold...next stop $1.62 = .618 of whole move..
gl
A
BOCX break 3.20 and shes off to the races again imo /e
watching BOCX reversal upticks /e
agree chipped..they also have the luxury of time../e
bocx..any wave count here is corrective of impulse up imo...
from this point on such a huge move, trendlines can be your best friend to keep you out of trouble...draw across tops and bottoms and trade the break either way..so far, on 1 min. riding the dtl from HOD..
gl
a