FDA Calendar & Hot Bio Plays

[Aufan 1983]

We have all slapped ourself for missing a big Bio play. Take KERX for example. Several months ago KERX was trading around .20 and today its over 6.00

These plays are happening every week or two. How can we make better money playing this rapidly changing field? I think I have found one tool that should increase our odds. To obtain an FDA calendar can be somewhat expensive but the following site offers a free calendar with no strings attached. No sign up and no fees. Keep in mind the following site could be pushing certain stocks for their own gain but with that in mind the FDA calendar should be a great help.

FDA Calendar | BioRunUp.com - Riding the Waves of Biotech (http://www.biorunup.com/fda-calendar/)

[Aufan 1983]

A few Bio plays to keep an eye on. These may or may not be on the calendar and I suggest you do your own DD. I'm either watching for an entry or already in these plays.

CLDX @ 8.40 ... HUGE pipeline. I'm in this one @ 7.55

KERX @ 6.00 ... In this one @ .29, 4.47, 5.20 and 5.90. *** Had a ton of shares @ .29 but sold most all of them for only a small gain.

APPY @ 3.80 .... Watching

ONCY @ 2.95 ... In @ 2.76


Will add more as they come

[Aufan 1983]

IMTN fell yesterday from 45.00 down to 7.80. FDA ordered new trial.

In at 8.95

[fz4fun]

IMTN fell yesterday from 45.00 down to 7.80. FDA ordered new trial.

In at 8.95

Do you mean ITMN (Intermune) --- got absolutely drilled on FDA news. Could be good bounce play---but may also sit in $10 range until the smoke clears. Nice entry at 8.95. Should make some green from there

[Aufan 1983]

Do you mean ITMN (Intermune) --- got absolutely drilled on FDA news. Could be good bounce play---but may also sit in $10 range until the smoke clears. Nice entry at 8.95. Should make some green from there


Yeah...lol... ITMN I always get my symbols goofed up. Remember I'm the conehead that wasted 500.00 by putting the wrong symbol in on a buy :rotfl:

I'm going to hold these for a week or two and see what happens. My son also bought in @ 9.60. We shall see what happens

[fink]

I likr IMGG and looking bto load the boat when and if this latest MoMNo run dies down.
Praying for no word for 2 weeks.

Itys a shorty, and as a typical Pharma nobody knows.

GE Toshiba and seinens and probably a fe others have been in contact with the company for possible marketing agreement after a positive FDA word.

third stall for more info was 60+ days ago. What more could they want? LOL!

[fink]

I like IMGG and lookingbto load the boat when and if this latest MoMo run dies down.
Praying for no word for 2 more weeks.

Its a shorty, and as a typical Pharma nobody knows.

GE Toshiba and seinens and probably a few others have been in contact with the company for possible marketing agreement after a positive FDA word.

third stall for more info was 60+ days ago. What more could they want? LOL!

[Aufan 1983]

VVUS was turned down today so on to the next play. I owned VVUS but got scared and sold yesterday.. Thank the lord above. VVUS was trading down roughly 55% in after hours.

NEXT FDA PLAYS:

JAZZ @ 8.65 has a date of July 20th to face the FDA panel. Bio players leaving VVUS should start entering JAZZ.

MELA @ 6.80 has a date of July 26

After watching the bio plays recently I have decided the best way to play these is to buy during or just before the run up to the FDA date. Sell 75% or in my case all before the decision is made. The FDA can be brutal

[Manolis]

FDA Grants Orphan Drug Status for Personalized Cancer Vaccine, BiovaxID(R), Targeting Mantle Cell Lymphoma


TAMPA, Fla. & MINNEAPOLIS, Jul 26, 2010 (BUSINESS WIRE) -- Biovest International, Inc. (OTCQB: "BVTI") today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID(R), Biovest's personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company's regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin's lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

With FDA Orphan Drug Status granted for this second indication, Biovest gains seven-years of market exclusivity for BiovaxID upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

According to Biovest's Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, "Orphan Drug Designation is an important step in our regulatory strategy. With promising clinical trials now complete in both follicular lymphoma and mantle cell lymphoma, we are preparing to seek regulatory approvals for BiovaxID in two separate indications. In addition to our ongoing regulatory efforts with regard to follicular lymphoma, we look forward to formally presenting our mantle cell Phase II clinical trial results to the FDA, and potentially the EMEA, later this year, as we explore potential expedited market registration pathways to offer this therapeutic vaccine regimen as a new treatment option for mantle cell patients."

In the BiovaxID mantle cell lymphoma Phase II study, tumor-specific immune responses were observed in 87% of the patients vaccinated with BiovaxID following rituximab-containing chemotherapy (EPOCH-R). Consistent with all other BiovaxID studies, the vaccine was very well tolerated and safe.

Biovest's President, Samuel S. Duffey added, "As we prepare to exit reorganization as a fully restructured public company, we remain firmly committed to our goal to bring needed new therapies to patients suffering with lymphoma. I am pleased that we received Orphan Designation for mantle cell lymphoma, and I am excited about our opportunity to potentially advance the role of personalized cancer vaccines for the treatment of lymphoma."

[bigbreak]

Any opinions on ecpt?