I got in at 22.49 in per-market.
Hoping for a bounce today!

I had to buy some more at 2.49.
It was just too cheap to pass up!

Just an incredible price right now.
This is for a company that received FDA approval and has Cardinal as a partner to take the product to market for what will clearly be the preferred imaging technique for breast, melanoma and head & Neck carcinoma.
I already have a huge position, but I'm considering buying more at these levels.
The price is closing in on where it was when we were not at all sure about the FDA decision!

Are folks worried about the earnings report due out April 29 or people are just taking profits?
Took a big hit in PPS yesterday.
Is this a good buying opportunity? I'm in here at average PPS of $57.26

NAVB

Navidea's Presentation of Top-Line Interim Analysis of Lymphoseek(R) Head and Neck Phase 3 Trial Selected for Investigator Award


- Data presented at the 2nd International Symposium on Thoracic and Upper Aerodigestive Malignancies -

DUBLIN, Ohio, Apr 11, 2013 (BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that a presentation of results from its Phase 3 clinical trial of Lymphoseek(R) (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma received the 1st Investigator Award at the 2nd InternationaI Symposium on Thoracic and Upper Aerodigestive Malignancies. The symposium was held April 4-6, 2013 in Athens, Greece. The presentation of recently announced top-line interim results for the Phase 3 Lymphoseek study and a summary of results from three of the study's highest-accruing clinical trial sites were made by Dr. Michael Blue, MD, Senior Medical Director of Navidea Biopharmaceuticals, one of the authors.
Poster Title:

The CD206-Targeted, Molecular Sentinel Node Mapping Agent Tc99m-Tilmanocept Accurately Stages Head/Neck Squamous Cell Carcinomas (HNSCC): Prospective Interim Analysis Results From a Phase-3 Multi-Institutional Study.

Authors:

Frank Civantos, MD, FACS, University of Miami; Stephen Y. Lai, MD PhD, FACS, The M.D. Anderson Cancer Center; Amit Agrawal, MD, FACS, Ohio State University Wexner Medical Center; Douglas B. Chepeha, MD, MSP, University of Michigan; Kevin T. Brumund, MD, FACS, UCSD Medical Center; and Frederick O. Cope, PhD, Michael Blue, Wendy Metz, PhD, Bonnie C. Abbruzzese, MS, CCRA, Navidea.

The results presented by Dr. Blue et al included a summary of the pre-planned statistical interim analysis of the primary endpoint on the entire study, as recently announced by Navidea. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (that is, lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Thirty-nine subjects were determined to have pathology-positive lymph nodes and were included in the interim analysis. Results from these 39 subjects demonstrated that Lymphoseek accurately identified 38, for an overall False Negative Rate (FNR) of 2.56%.

In addition, the authors reviewed a preliminary evaluation of the NEO3-06 trial data from three of the highest-accruing clinical sites. A total of 50 subjects were evaluated from these sites; 21 had pathology-positive lymph nodes. Results indicated that Lymphoseek identified these pathology-positive lymph nodes in 21 out of 21 subjects for an FNR of 0%. The total patient population included subjects with tongue tumors, floor of mouth tumors and other intraoral head and neck tumors. The authors concluded: "(99m)Tc-tilmanocept demonstrated that the SLN status was highly predictive and consistent with the status of the neck for clinical stage and tumor location." They also noted that "timing of (99m)Tc-tilmanocept injection resulted in no difference in regards to pathology findings," in study subjects who had same day surgery versus next day surgery.

Navidea's Phase 3 clinical trial (NEO3-06) is a prospective, open-label, multicenter, within-patient study of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection. It is designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma.

The NEO3-06 study is a supplement to previously conducted Phase 3 trials of Lymphoseek in breast cancer and melanoma that were designed to establish Lymphoseek as an effective radiopharmaceutical agent for use in lymphatic mapping procedures to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Those studies formed the basis of the NDA registration package upon which the U.S. Food and Drug Administration based its U.S. approval of Lymphoseek in March, 2013. Navidea is conducting the NEO3-06 clinical study to provide evidence of Lymphoseek performance in a third cancer type and to potentially expand its product label

I don't think you could sell at market on equities under $1.00
Pretty sure it was just someone that wanted out in a hurry.

Me too at 23.49
Upgraded today
Should move up from here over the next few days.

NAVB started as a buy in AH by J Mont. with price target of $5

I took some off his hands at .80 today!

Not the case at all here.

You can get compassionate use especially when it is cheaper in the long run than the pathology bill for tedious lymph node mapping.

I think this will fly once it hits the market.

The medical-legal issues are addressed in the increased risk of radical lymph node dissection.

I can see doctors going straight to LS instead of putting patients through a much more radical surgery!

Keep in mind that they are considering stopping the randomization early because they don't feel that it is fair to the non-treatment arm cohort!

That says it all!!

NAVB should start to climb now with FDA approval and excellent top line data!

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, announced top-line results from the interim analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma.

According to a release, results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma of the head or in the mouth, as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Multiple level nodal dissection surgery is considered the "gold standard" to determine the presence and extent of cancer spread in lymph nodes of patients with head and neck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food and Drug Administration in March, for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

"These interim results are highly encouraging for this patient population who generally face extensive surgery to properly stage their cancer," said Mark J. Pykett, V.M.D, Ph.D., President and CEO of Navidea. "This study is part of Navidea's strategy to expand Lymphoseek utilization into multiple cancer types and assist physicians in improving the accuracy and extent of cancer diagnosis for their patients. In light of the positive top-line results, and with consideration for the effect of these surgeries on patients, the study's Data Safety Monitoring Committee (DSMC) has recommended that we close the NEO3-06 trial early, a possibility the Company will assess as the full dataset becomes available. We expect to complete the full dataset and secondary analyses of this study, present them at major scientific meetings in the coming months, and evaluate the possibility of filing a Supplemental New Drug Application (sNDA) later this year."

"In the current standard of care with head and neck tumors, we may systematically remove as many as 60 or more lymph nodes within the neck during a formal dissection procedure, a large number due to the likelihood that patients may have hidden cancer in the lymphatic system," said Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. "The use of sentinel lymph node biopsy for selected patients with head and neck cancers is in evolution. These combined interim data, along with our initial clinical experience with Lymphoseek, suggest a very high level of accuracy in the identification and mapping of SLNs that may significantly improve the precision and practicality of SLN mapping procedures, and provide precision staging that may help direct post-surgical treatment. We look forward to developing the full potential of this technology for the appropriate patients," added Dr. Lai.

"This clinical study is unique in that it compares the performance of Lymphoseek, a next-generation, receptor-targeted synthetic molecule to the pathological 'gold standard' multiple level dissection procedure in which a large portion of the head and neck lymph node tissue is removed," said Frederick Cope, Ph.D., F.A.C.N., Senior Vice President of Pharmaceutical Research and Drug Development at Navidea. "Achieving this degree of statistical significance versus the pathology of a multiple level dissection is testimony to the accuracy of Lymphoseek in identifying clinically significant lymph nodes through a less invasive diagnostic procedure."

More information:

www.navidea.com

((Comments on this story may be sent to newsdesk@closeupmedia.com))

This is HUGE! Great news for patients who can now avoid radical and, many times, disfiguring surgery!

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, announced top-line results from the interim analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma.

According to a release, results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma of the head or in the mouth, as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Multiple level nodal dissection surgery is considered the "gold standard" to determine the presence and extent of cancer spread in lymph nodes of patients with head and neck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food and Drug Administration in March, for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

"These interim results are highly encouraging for this patient population who generally face extensive surgery to properly stage their cancer," said Mark J. Pykett, V.M.D, Ph.D., President and CEO of Navidea. "This study is part of Navidea's strategy to expand Lymphoseek utilization into multiple cancer types and assist physicians in improving the accuracy and extent of cancer diagnosis for their patients. In light of the positive top-line results, and with consideration for the effect of these surgeries on patients, the study's Data Safety Monitoring Committee (DSMC) has recommended that we close the NEO3-06 trial early, a possibility the Company will assess as the full dataset becomes available. We expect to complete the full dataset and secondary analyses of this study, present them at major scientific meetings in the coming months, and evaluate the possibility of filing a Supplemental New Drug Application (sNDA) later this year."

"In the current standard of care with head and neck tumors, we may systematically remove as many as 60 or more lymph nodes within the neck during a formal dissection procedure, a large number due to the likelihood that patients may have hidden cancer in the lymphatic system," said Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. "The use of sentinel lymph node biopsy for selected patients with head and neck cancers is in evolution. These combined interim data, along with our initial clinical experience with Lymphoseek, suggest a very high level of accuracy in the identification and mapping of SLNs that may significantly improve the precision and practicality of SLN mapping procedures, and provide precision staging that may help direct post-surgical treatment. We look forward to developing the full potential of this technology for the appropriate patients," added Dr. Lai.

"This clinical study is unique in that it compares the performance of Lymphoseek, a next-generation, receptor-targeted synthetic molecule to the pathological 'gold standard' multiple level dissection procedure in which a large portion of the head and neck lymph node tissue is removed," said Frederick Cope, Ph.D., F.A.C.N., Senior Vice President of Pharmaceutical Research and Drug Development at Navidea. "Achieving this degree of statistical significance versus the pathology of a multiple level dissection is testimony to the accuracy of Lymphoseek in identifying clinically significant lymph nodes through a less invasive diagnostic procedure."

More information:

www.navidea.com

((Comments on this story may be sent to newsdesk@closeupmedia.com))

It should have closed at 2.67
I was watching the final 2 minutes. You could see them trying to bid it down but the ask kept getting hit.
They finally painted it down just at the close to 2.65.
This will run soon enough.
I'm in here for the long run.

CVR Energy Subsidiary CVR Refining Reports Minimal Investment Required To Meet EPA Proposed Tier III Standards

Wednesday 04/03/2013 12:04 PM ET - Pr Newswire via COMTEX

CVR Refining, LP (NYSE: CVRR), a subsidiary of CVR Energy, Inc. (NYSE: CVI), today announced that the proposed U.S. Environmental Protection Agency Tier III sulfur regulations will have no impact on the company's previously announced full year 2013 distribution guidance of $5.50 to $6.50 per common unit. The midpoint of this guidance represents a distribution yield of 19 percent based on CVR Refining's closing common unit price on April 2, 2013, of $31.47.

I agree.
I think the smart shorts covered in the 2.40's.

I'm keeping my shares but not looking for any significant moves to the upside for 6-8 months.
I can afford to be patient looking for 1000% from these levels in about a year.

Starting to move.
This will continue to climb as we get closer and closer to PDUFA and almost certain approval on April 30.
GLTA

I agree that this will eventually fly.
Once the games are done, this is easily over $5

I'm in here at 3.93
I Ike the recent moves and the Ohio play should pan out.

Should really start to move up this quarter!
I'm in here at 20.94
Let's get on the road!

Thanks for the post.
This has turned into a long-term investment for me.
It is no longer a "trade".
At this point next year, we should all be smiling!

Yes. Nice move. I got in at the open, but had to take profits at the end of the regular session on that awesome move.
I will look to re-enter again lower.
Great day!

I'm still in here. Averaged down to .55

Watching here with interest!
May get in next week.
I like the volume!

Some news from the company would be helpful.
I do agree that we are seeing a little bit of institutional money in here now.
The volume needs to be consistently over 200k for this to move up substantially.

Well played!
You had to have some nads to short from .61 when there was such a high probability of approval. Good for you!
I took a hit, but bought some more at .31 and made some back.
I believe this will still work out in the end. It's just going to take longer.

I'm back in here at 15.81 after flipping it several times.
We shall see.
It has been very good to me so far (as the song goes)!

That's very true, but it's an artificial negative catalyst.
It should bounce back to close to 13 very quickly.
I bought some cheap shares today.

No. The company is well positioned for the next four quarters.
I do not believe it will take long to address CRL issues.
The good news is the FDA did not raise questions regarding the drug itself.
Should be a simple fix. I see re-submission within 2 quarters.

I'm holding

.30 is too low.
Over reaction!
Should bounce back to high .30's or low .40's
Should be a nice bounce play here for today

Agreed.
Good news in a way.
Shows it will get fixed quickly and approved. It's just a longer term investment now.
I will keep my shares!

Congrats to you.
This just changed for me from a trade to an investment.
I will hold it now for another 12 months.

Pre-market tomorrow

It will probably be in ore- market tomorrow.

Great day here

He sold for a loss around .655

I think your audience here are the ones left standing.
We are strapped in for approval.
I doubt that you can encourage many left here now to sell.
Good luck with your short position.
Be ready to cover quickly when it is approved

Yep!

Agreed!