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Trading FDA, Clinical Trial Binary Events: $BHRT.OB $GNBT $IRIS $ACTC.OB $GERN

By Mike Havrilla on 08/02/2010 – 7:18 am PDTLeave a Comment

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

According to a recent SEC filing, Bioheart (OTCBB:BHRT)  announced that it received a written notice of default from failure to pay a $1.33 million Bank of America loan at the maturity date of 7/5/10. The Company is currently working on potential debt restructuring with third parties with a pending Phase I REGEN study of MyoCell (patient-derived regenerative stem cell therapy) in patients with congestive heart failure (CHF) to be conducted in Jordan to support a potential FDA Phase II/III MARVEL study.

On 7/28/10, Generex Biotech (NASDAQ:GNBT) announced that 75% of the required number of per-protocol completers in its ongoing six month pivotal global study of Generex Oral-lyn (recombinant human insulin, buccal spray). GNBT anticipates an expected early 2011 completion date and a formal interim analysis is planned after 90-day results for all subjects to support a potential non-inferiority claim to standard injected insulin therapy.

In late April 2010, Iris International (NASDAQ:IRIS) announced a FDA 510(k) submission for NADiA ProsVue (a prostate cancer prognostic test), seeking marketing clearance for a lab-based diagnostic test designed to help physicians identify patients at low risk of prostate cancer recurrence post radical prostatectomy. To support the potential commercialization of this test and other lab-based personalized medicine tests, IRIS reported that it closed an acquisition of a CLIA-certified lab (AlliedPath) this morning.

On 7/28/10, Advanced Cell Technology (OTCBB:ACTC) submitted additional information to the FDA for its Retinal Pigment Epithelial (RPE) Cells from Human Embryonic Stem Cells (hESCs), seeking clearance to conduct an early-stage study in patients with an eye disease known as Stargardt’s Macular Dystrophy (SMD). ACTC filed the IND in Nov. 2009 and expects to receive FDA clearance to begin the study during 3Q10 and begin treating patients 4Q10.

On 7/30/10, Geron (NASDAQ:GERN) announced FDA clearance and lift of a clinical hold for GRNOPC1 (a human embryonic stem cell or hESC product candidate) to conduct a Phase I safety study in patients with acute spinal cord injury which will also evaluate secondary efficacy endpoints. Based upon established safety in this study, Geron plans to seek approval to both increase the dose and expand the study to include patients with severe incomplete injuries.

Below are summaries of the most recent articles written by Mark Messier at - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing…

This Week’s Watchlist 8/2/10: $ARNA $ISA.TO $JAZZ

ARNA - Arena continued its amazing climb last week, actually tapping $8.00 before closing at $7

Related Articles:

  1. Trading FDA, Clinical Trial Binary Events: $ATHX $AZN $VRTX $MKGAY
  2. Trading FDA, Clinical Trial Binary Events: $AIS $HOLX $OMER $CPD
  3. Trading FDA, Clinical Trial Binary Events:$ONXX $BIO $ARNA
  4. Trading FDA, Clinical Trial Binary Events: $MNKD $AXN $GERN
  5. Trading FDA, Clinical Trial Binary Events: $DSCI $IRIS $VVUS

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