Here's the timelines........The BMOD Story by The Rainmaker
September 2009 BMOD finishes up the first cohort of the trial and they think they are done. BMOD see's Cypath is going to be really big, Cypath works amazing. BMOD CEO tells investors results will out by December 2009. They find a much higher percentage of cancer positives from the New Mexico Vets than they thought. Cypath is BMOD's golden ticket. So BMOD wisely decides we better bring on a big name Clinical Investigator to make 100% sure we do this right and they hire Dr. Bauer.
This is where BMOD story gets interesting......This is my interpretation of what happened based on all the info I have read and interviews I listened to.
Dr. Bauer who is the man btw.....looks at the trial, and says you need to add a second cohort to show senstivity of Cypath. FDA will make you do it anyway, you might as well get it right now.
JC probably has a mini heart attack as he told everyone results by December 09. Dr. Bauer says don't sweat it, you only need 21 people who have been diagnosed with lung cancer to take the test right after they are diagnosed with lung cancer and have not started any treatment. Don't worry JC I'll find you the 21 subjects at my hospital, Christiana. It won't take that long.
So JC regroups himself and tells investors about the second cohort and says results by March 2010.
March comes around and that second cohort Dr. Bauer added turns into a real bitch. These poor people just find out they have lung cancer and you say to them, sorry for your bad news would you mind blowing into this lung flute for a trial we're doing. The people look at them and say my life is falling apart and you want me to do what. Others take the test, go off to start chemo afterwards. Months later BMOD needs them back one more time for a followup exam. Some of them miss exams are pretty sick and its probably hard for BMOD to say please, please come back for the followup its for our trial.
Now June 2010 comes and miracle of miracles Dr. Bauer finds them the 21 people who meet all the criteria, take the Cypath test and come back for their follow up exam and BMOD finishes their testing. They tell us great news, testing is done Dr. Bauer is finishing his report and we have what we need to move on to Commercialization and Phase 3 approval. We will release results when Dr. Bauer finishes his report.
July comes no results, August no results, September nothing...then October 3rd bam.......We find out BMOD has been going back and forth with the FDA all this time. Turns out some of those 21 samples that were so hard to get, have a problem. Not a problem with Cypath mind you....Cypath is the real deal and works like a charm. This is probably the key point to take away from this story. The problem with the samples was that some of those 21 people had cancer that started somewhere else in their body and it spread to their lungs afterwards.
Stock gets crushed in one day when this news came out. Goes from .18 to .10 within an hour of the open. Now none of us know how friggin long it is going to take them to replace those samples. Stock sinks on low volume the rest of 2010 down to .07 Eventually they bring on a second recruiter, Waterbury to help them find the rest of the subjects they need.
January 2011 same deal no idea when they find enough people and report those Phase II results......now BMOD at 7 cents when we had no idea when they would ever find those people was probably the right price.
Then our miracle comes, BMOD's miracle comes....people whose life BMOD's Cypath will save one day down the road from early detection of cancer, all of those peoples miracle comes in too. So wishing you bought those .07's knowing what we know now is not realistic. This is a different company now that this PR came out and our miracle, my miracle came in. This is the beinning of one of the great runs for a stock and one of the biggest feel good stories where for once the goods win in the end. Real wins over pretend and something that has taken years and years to develop and bring to this magnificent boiling point is about to come to fruition. I really hope many of the people who I have met here on ihub over the years who are hurting from these penny stocks read this story and hear these words.....and join me here with BMOD.
This PR that changed it all and put BMOD on the doorstep of greatness.
I just need them to take a few more steps to ring the door bell....and I believe from the bottom of my heart, destiny will there to open that door.
Biomoda Completes Patient Enrollment and Sample Collection for Pilot Study Feb 22, 2011 07:00:16 (ET)
ALBUQUERQUE, N.M., Feb 22, 2011 (BUSINESS WIRE) -- Cancer diagnostics company Biomoda, Inc. (BMOD, Trade ) ( www.biomoda.com ) today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath(R) diagnostic assay for the early detection of lung cancer.
"We are working closely with Dr. Thomas Bauer, Principal Investigator of the CyPath(R) study, and Dr. Richard Holcomb of Quintiles to evaluate and report top-line results by the end of first-quarter 2011," Biomoda Chief Executive Officer Maria Zannes said. "We believe initial results will show that our assay can both identify and quantify lung cell characteristics that differ between groups of individuals at high risk for developing cancer and those who already have the disease."
The pilot study consisted of two cohorts: (1) a high-risk group of military veterans who smoked more than 20 "pack years" and (2) a smaller positive control group made up of patients diagnosed with lung cancer who have not started treatment.
"We are grateful to the lung cancer patients who participated in our pilot study at a difficult time in their lives," Biomoda President John Cousins said. "Thanks to their selflessness and the efforts of our partners at Christiana Care Health System and Waterbury Pulmonary Associates, we were able to meet our study requirements."
Currently for investigational use only, the CyPath(R) labeling solution binds to cancer cells and causes them to fluoresce under specific frequencies of light. Biomoda is seeking Food and Drug Administration (FDA) approval of its diagnostic technology as a Class III medical device.
AI
