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Agent & Drews Bio Plays - Page 4

post #61 of 586
12/14/10 at 5:46pm
Thread Starter 
Man I gotta lay off the drinks at lunch. Got in at .95
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post #62 of 586
12/14/10 at 5:48pm
Quote:
Originally Posted by AgentBearBull View Post
Man I gotta lay off the drinks at lunch. Got in at .95
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post #63 of 586
12/14/10 at 8:52pm
Thread Starter 
That's some weak EOD action on ANDS
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post #64 of 586
12/15/10 at 4:59am

Some DD on RPTP

RPTP notes

OS: 30.21 Million

Drug: Delayed Release Cysteamine

-phase 3 study expected to be complete 4Q10 with results
expected 1Q11 to support potential NDA

-Cysteamine bitartrate has been used to treat cystinosis since 1978

-DR Cysteamine is a delayed release formulation of cysteamine bitartrate

-Only 2000 known cases in the world (orphan drug status)

-Current dose for Cysteamine bitartrate is every 6 hours compared to
DR Cysteamine twice daily (30% lower)

-Primary endpoint- Steady state white blood cell cystine levels in DR
Cysteamine compared to immediate release Cysteamine
Bitartrate

-The majority of RPTP's senior management were previously employed by
BioMarin (BMRN) prior to 2005 and during that time had 2 orphan drugs
approved by the FDA (Naglazyme May05 and Aldurazyme April03)

-Raptor is also in Phase 2 trials with DR Cysteamine for potential treatment of
Huntington's Disease and Non-alcoholic Steatohepatitis (NASH)

We know that immediate release cysteamine is effective in treating cystinosis but the question is, does the delayed release have the same effect as the immediate release and will it meet the endpoint. It would be nice to have someone with a medical background take a look at the trial and chime in. (HINT HINT)

Drew
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post #65 of 586
12/15/10 at 12:31pm
Thread Starter 
Quote:
Originally Posted by Drewett27 View Post
RPTP notes

-The majority of RPTP's senior management were previously employed by
BioMarin (BMRN) prior to 2005 and during that time had 2 orphan drugs
approved by the FDA (Naglazyme May05 and Aldurazyme April03)


Drew
Got to like that.
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post #66 of 586
12/15/10 at 2:40pm
Thread Starter 
ANX up almost 6% on news:

SAN DIEGO, Dec. 15, 2010 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.

"We have performed an extensive analysis of the data from our bioequivalence study of ANX-514, as well as on results from other trials using Taxotere®, and plan to discuss our findings at the meeting," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

"Based in part on the substantial variability observed with Taxotere as reported in the literature, we believe the transitory elevations in total docetaxel concentrations for ANX-514 do not affect adversely its safety or efficacy relative to Taxotere. However, the FDA is the final arbiter of safety and efficacy and, following our meeting, we will provide an update on the next steps and requirements for advancing ANX514 toward an NDA submission," Mr. Culley continued.

About ANX-514

ANX-514 is a novel emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is being developed to reduce the incidence and severity of side effects associated with detergents, such as hypersensitivity reactions.
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post #67 of 586
12/15/10 at 2:50pm
Quote:
Originally Posted by AgentBearBull View Post
ANX up almost 6% on news:

SAN DIEGO, Dec. 15, 2010 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.

"We have performed an extensive analysis of the data from our bioequivalence study of ANX-514, as well as on results from other trials using Taxotere®, and plan to discuss our findings at the meeting," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

"Based in part on the substantial variability observed with Taxotere as reported in the literature, we believe the transitory elevations in total docetaxel concentrations for ANX-514 do not affect adversely its safety or efficacy relative to Taxotere. However, the FDA is the final arbiter of safety and efficacy and, following our meeting, we will provide an update on the next steps and requirements for advancing ANX514 toward an NDA submission," Mr. Culley continued.

About ANX-514

ANX-514 is a novel emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is being developed to reduce the incidence and severity of side effects associated with detergents, such as hypersensitivity reactions.
Dang, I was waiting on ANX to pull back a bit more before jumping in.
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post #68 of 586
12/15/10 at 3:06pm
Quote:
Originally Posted by Drewett27 View Post
Dang, I was waiting on ANX to pull back a bit more before jumping in.
And I got in too early and am now break even LOL
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post #69 of 586
12/15/10 at 3:42pm
MNKD at 9$, too late to get in?
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post #70 of 586
12/15/10 at 3:56pm
Quote:
Originally Posted by stockss View Post
MNKD at 9$, too late to get in?
Too late for me. RSI overbought, Full STO and PPO topped out on daily. I just don't see much reward here given the risks at this level. If you're dead set on buying it I'd certainly wait for a pullback.

Drew
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post #71 of 586
12/15/10 at 4:03pm
Quote:
Originally Posted by stockss View Post
MNKD at 9$, too late to get in?
I sure hope so as I sold under 8
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post #72 of 586
12/15/10 at 4:50pm
Thread Starter 
Added to RPTP today at 3.69
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post #73 of 586
12/15/10 at 5:08pm
Still holding ARIA Jan $4 calls. Looks like it's locked into that power zone right now.
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post #74 of 586
12/15/10 at 6:39pm
Thread Starter 
Quote:
Originally Posted by AgentBearBull View Post
Added to RPTP today at 3.69
Jumped on this way too early.
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post #75 of 586
12/15/10 at 6:41pm
Quote:
Originally Posted by AgentBearBull View Post
Jumped on this way too early.
I just grabbed a few more at 3.63 I'm thinking it may bounce off of the 200MA on the 60 min
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post #76 of 586
12/15/10 at 7:37pm
Quote:
Originally Posted by Drewett27 View Post
I just grabbed a few more at 3.63 I'm thinking it may bounce off of the 200MA on the 60 min
So much for it bouncing
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post #77 of 586
12/15/10 at 8:05pm
Quote:
Originally Posted by stockss View Post
MNKD at 9$, too late to get in?
Yes, it was too late.

Hope you did not buy.. $7.75 now
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post #78 of 586
12/15/10 at 8:08pm
Quote:
Originally Posted by Bigcat View Post
Yes, it was too late.

Hope you did not buy.. $7.75 now
Man, I almost grabbed some $9 puts this morning right after we had that conversation and didn't. I've made all the wrong moves today.
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post #79 of 586
12/15/10 at 8:10pm
Thread Starter 
Quote:
Originally Posted by AgentBearBull View Post
Added to RPTP today at 3.69
Quote:
Originally Posted by Drewett27 View Post
I've made all the wrong moves today.
Likewise
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post #80 of 586
12/15/10 at 8:26pm
Quote:
Originally Posted by Drewett27 View Post
Man, I almost grabbed some $9 puts this morning right after we had that conversation and didn't. I've made all the wrong moves today.
I'm on 2 days in a row.. But my moves are costing me money LOL.. At least you just missed possible profits.

We will get back on track soon. It only takes one really good play. We just need to find it. Everything else is just gambling IMO
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