Per 13F filing yesterday, BB added 1 million shares to the total of 5,428,591 shares. They are very confident on holding AVNR shares and think that AVNR will be much higher in the long run.
They may know something that retail investors don't know! So, hold your shares tight and don't let the shorts scare you.
All the best!
I anticipate for some news today regarding to the BLA. Today is the 74th day and FDA will communicate with the company regarding the BLA application.
It's good news that Canaccord realizes the company potential but BLA acceptance is still up on the air for the time being.
It is strange to what happens to PGNX and some other biotech in general as well. It makes me believe a lot of what happens in the stock market is directly analogous to a hold'em game.
For example, the dealer--PGNX--has already shown their hand (or at least shared with you the phase 2 data of PSMA-ADC and told you what to expect). Your opponent, the street, who has the big stacks, has completely slow-played this one. However, they place big bet on the river.
Do not throw away your hands and let them bully you away. The phase 2 data of PSMA-ADC is promising with CTC reduction of 50% or more in 70% of the patients with low NE.
Good things is about to come.
The company will present the data at Genitourinary Cancers Symposium Meeting in San Francisco in January 16-18, 2014. Stay tuned!
We have a new, great, top of the line CEO so I don't think the buyout is near. If everything is going as planned, I see HALO is in the $30s by year end. HALO has a great pipeline and it will be in the $100s in 2-3 years.
I can't wait to hear the JP Morgan presentation on the 16th. Be patient!
NKTR issued a news release of the special monitor committee told the company to move ahead with the phase 3 trial pending the topline phase 2 result announcement in March. It is almost the same as PGNX.
An oncologist that I know provides the following opinion:
It appears that the trial drug, PSMA-ADC does have some anti-tumor effect in a significant subset of this group of study patients. However, the abstract deals exclusively with laboratory findings, which are customarily associated / linked with the disease process, rather than offering direct incite into any observed and relevant tumor responses. Hopefully, we will get a better total picture when the clinical and radiological follow-up to date is presented at the conference tomorrow.
Good luck to all longs!
Yup! Baker Brothers own 20,943,673 shares of SGEN or 17.1% of the total 122,481,320 shares of the Issuer’s common stock outstanding as of November 5, 2013, as reported in the Issuer’s quarterly report on Form 10-Q filed with the SEC on November 8, 2013.
I will buy more tomorrow.
I thought that you are busy to accummulate more shares and options of ITMN for the whole morning bud. Congratulations!
Study conduct in ASCEND remains excellent with a level of patient retention in the study that exceeds 90 percent. More than 95 percent of eligible patients (those patients who remain on blinded pirfenidone or placebo therapy) who have completed the ASCEND study have decided to enter the open-label RECAP extension study. RECAP is a study in which all patients receive pirfenidone. RECAP also includes patients rolled over from the company's prior CAPACITY program which completed in late 2008 and enrolled 779 patients in two Phase 3 studies. RECAP provides valuable long-term safety data that further expands the already large safety database for pirfenidone in patients with IPF.
Please listen to the NPSP Analyst and Investor Event on December 6, 2013 08:30 ET in New York, NY. Especially at the Q& A at the end on slide 123.
FDA Plan the Review for BLA ( 21st Century Review).
1. Decide fileability (reviewers should bring completed discipline filing review templates to the filing meeting)
2. Identify significant review issues, including labeling or REMS deficiencies, for the Filing Communication (Day-74 letter)
3. Determine final review classification (standard or priority designation) (See MAPP 6020.3)
Please Google FDA BLA Review Process.
Based on the Q3 report, ITMN will not report the top line result of the ASCEND trial until the second quarter of 2014--Which means that the time frame is between April - June.
Here is the quote from the Q3 report: "Study conduct in the ASCEND Phase 3 study remains excellent with a level of patient retention in the study that exceeds 90 percent. More than 90 percent of eligible patients who have completed the ASCEND study have decided to enter the RECAP open-label extension study in which all patients receive pirfenidone. ASCEND is InterMune's confirmatory Phase 3 study of Esbriet in 555 IPF patients to support marketing approval in the United States. InterMune currently expects to report top-line results from ASCEND in the second quarter of 2014 and intends to present the results at the May 2014 International Conference of the American Thoracic Society (ATS) in San Diego."
So I don't see anything will be reported before that time frame unless something excited that the company wants to share.