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Proteo is currently setting up a pivotal phase III clinical trial for the prophylactic treatment of acute postoperative complications after resection of esophageal cancer, after a phase II multi-center trial had demonstrated that Elafin treated patients needed a significantly shorter stay in the intensive care unit as compared to placebo patients. In a further phase II study in patients undergoing coronary artery bypass surgery, a significant reduction of the circulating cardiac damage marker Troponin I at 6 hours after surgery was observed.
Only small position here...but PTEO is in my daily screen shot, ready to add.
I like recent forward steps and today insider buying.
You still following this? What do you hear?
Hey. You still following this? I've been looking into it. Like the share structure and balance sheet. I'm long some of the company that lent these guys the money. Ngrc. They just did a rto into the shell.
New here, built a small position with plan to add more...hard to fill (on bid size all week long).
Very promising and undervalued stock, no one put 4,8 mil.$ if not very confident about approval coming....furthermore, current mkt.cap is half of financing alone!
Float insane tiny...anything can happen...
"TOP REASONS TO BUY Proteo (PTEO) NOW
PTEO has had ORPHAN drug status granted for for it's lead drug Tiprelestat (Elafin) BOTH in the European Union AND the United States.
(Orphan drug status is a VERY GOOD status to receive, Proteo (PTEO) received it on BOTH continents from the FDA and their European counterparts the EMA)
On May 20th 2014, Proteo (PTEO) signed an agreement with Biotech Development Corp. (BDC) who gave them total funds of EURO 3.5 million (approx. US$ 4.8 million) in return for a share of future revenues for Tiprelestat (Elafin).
(Wow, you only ante up that kind of money if you are VERY CONFIDENT APPROVAL for drug is coming!)
In February 2014, Proteo (PTEO) received Protocol Assistance (scientific advice for orphan medicines) from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) with respect to the strategy for further clinical development and marketing authorization for Tiprelestat (Elafin)
(There's the answer, the European Medicines Agency (EMA) is taking them under their wing and helping guide them toward APPROVAL. No wonder Biotech Development Corp. was eager to ink a multi million dollar deal with Proteo!!!....It really helps when the regulatory agency helps walk you through the process toward APPROVAL. Remember this company is ONLY going to invest all those millions if they believe that APPROVAL from the EMA is coming, they invested and for the rest of us that is a HUGE BUY SIGNAL!!)
With a LOW FLOAT of just 11.4 Million shares Proteo (PTEO) is under the radar and the share price is likely to move up quickly as news of the company spreads.
Amazingly the share price of Proteo (PTEO) is around .09 cents, the positive news has not yet caught up with the share price, BUT IT WILL, now is the time to BUY Proteo (PTEO) BEFORE the share price takes off!!
Proteo (PTEO) through it's wholly owned subsidiary, Proteo Biotech AG, that is a German corporation is a clinical stage biotech drug development company focusing on the development of anti-inflammatory treatments for rare diseases with significant unmet needs. Proteo (PTEO) intends to develop, promote and market pharmaceuticals and other biotech products.
Proteo (PTEO) lead product is Tiprelestat (Elafin) that prevents acute postoperative inflammatory complications. Tiprelestat (Elafin) ability to block the proteases that cause these undesirable effects makes it a promising drug for the treatment of various inflammatory diseases and post traumatic inflammatory complications.
Currently Tiprelestat (Elafin) is undergoing clinical trials for 3, yes..THREE different diseases:
Esophagus cancer surgery (Phase II completed, Phase III planning)
Coronary artery bypass surgery (Phase II ongoing)
Kidney transplantation (Phase II regulatory approval)
The excellent tolerability of Tiprelestat (Elafin) in human subjects has led to late stage clinical trials.
BUT IT GETS EVEN BETTER:
Proteo (PTEO) and it's Orphan Drug Designation:
In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as tax credits and extended exclusivity periods for the drug, all intended to encourage the development of drugs which might otherwise not have been developed.
Orphan Drug Designation has been awarded to the Proteo (PTEO) by the European Commission for the use of Tiprelestat (Elafin) in the treatment of esophagus carcinoma.
The U.S. Food and Drug Administration (FDA) has GRANTED orphan drug designation to Tiprelestat (Elafin) for the prevention of inflammatory complications of transthoracic esophagectomy AND for pulmonary arterial hypertension.
In February 2014, Proteo (PTEO) received Protocol Assistance (scientific advice for orphan medicines) from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) with respect to the strategy for further clinical development and marketing authorization for Tiprelestat (Elafin) when used for acute postoperative inflammatory complications after resection of esophageal cancer.
(Once again It really helps when the regulatory agency helps walk you through the process toward APPROVAL)
For the development of its lead product Tiprelestat (Elafin) Proteo (PTEO) has established a network of globally renowned research institutes, physicians and hospitals in the US and Europe. The development of Tiprelestat (Elafin) has been widely supported by public grants. Worldwide leading funding bodies, such as the American National Institutes of Health (NIH) and the British Medical Research Council (MRC), support preclinical and clinical studies on Tiprelestat (Elafin) with high volume grants.
(Most biotechs would be VERY ENVIOUS to have so many grants and major organisations paying for the research and development of their leading drug!)"
PTEO Break out coming, BIDS are starting to stack
PTEO The European Medicines Agency (EMA) is taking them under their wing and helping guide them toward APPROVAL. No wonder Biotech Development Corp. was eager to ink a multi million dollar deal with Proteo!!!....It really helps when the regulatory agency helps walk you through the process toward APPROVAL. Remember this company is ONLY going to invest all those millions if they believe that APPROVAL from the EMA is coming, they invested and for the rest of us that is a HUGE BUY SIGNAL!!)
PTEO Awesome news: On May 20th 2014, Proteo (PTEO) signed an agreement with Biotech Development Corp. (BDC) who gave them total funds of EURO 3.5 million (approx. US$ 4.8 million) in return for a share of future revenues for Tiprelestat (Elafin).
PTEO has ORPHAN drug status granted for for it's lead drug Tiprelestat (Elafin) BOTH in the European Union AND the United States
PTEO About to break out, low float with good news
So basically IR responded to your email with the same thing the PR stated.
I'll still wait for the 8K to be released or the FDA stating such before I will even look to put money into it. But that's just me.
email from IR:
"The FDA grants orphan drug designation to Elafin for prevention of inflammatory complications of transthoracic esophagectomy.
The orphan drug designation was established to encourage development of drugs that support the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the U.S. The designation provides U.S. market exclusivity for a seven-year period upon marketing approval for the designated indication and tax credits for clinical research costs.
Granting orphan drug designation does not mean that the FDA has given marketing approval for this indication."
Best regards,
Proteo IR Team
Proteo, Inc.
2102 Business Center Drive, Suite 130
Irvine CA 92612
USA
IR@proteo.us
Phone (949) 253 4155
Thanks for the insight, I don't usually play biotechs and it's good to know where to confirm prs!
Was thinking the same, usually BS news is followed by a big dump and it doesn't look like they are selling shares? Hmmm
If the news is real, then the company should be releasing an 8K in the next few days, as any "real" company would do to inform "investors"
I myself would wait on that confirmation.
well thats some odd stuff huh? i wonder what the error is here lol
For individuals that would like to search for themselves.
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm
When do you think that application was submitted? The FDA doesn't take an application one day and approve it the next.
Take a look at the FDA calendar, they tell you everything they are voting on and deciding on each day.
that was 12/28
Well congrats to whomever made money off of their fake news! LOL
News is false. A little DD goes a long way. According to the FDA it was not approved..
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