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Best day ever. made some killings in DCTH I made little over $800. Wow, i am feeling like a pro here.Originally posted by riverbabe View Post
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Kerx - Duniyo
Okay, took a look at Keryx Pharmaceuticals (KERX). They essentially have two products. One is in Phase 2 clinical trials (long time away). The other is in Phase 3 clinical trials under FDA study guidelines (this is good).
BUT, although part one of the Phase 3 trial (a short term study) is expected to complete in 4Q 2010, the part two long term study will take much much longer -- "Patient enrollment is expected to take approximately 6 to 9 months." and it is a "... 58-week long-term safety and efficacy study initiated today" ("today" was September 29, 2010). It's not clear whether the enrollment period is part of the 58-week study, but I suspect it's not.
So, bottom line is 6-9 months plus 58 weeks = approx. 1-1/2 to 2 years AND, although the early studies look promising, there is no telling what the long term study results will be. Then they will have some kind of data to submit to the FDA, looking at another maybe 9 months for approval (if granted) of the possible new drug application.
Anyway you look at it, this is a long term investment. If you really want to play it short term, maybe put in a little coin now-ish on a bet and get out with a quickie profit if the results of the short term study are positive in the 4Q. Otherwise, the next little pops could occur if they report positive study results at various biotech conferences, so watch the conference schedule news on their web site. Any major pops are a long way off around FDA decision. ...all JMHO of course...
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Alxa
I'm out. The Complete Response Letter does not bode well for Alexza's delivery system for any drug. The Letter said that "The agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004. (my emphasis)Last edited by riverbabe; 10-11-2010, 10:23 AM.Comment
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ALXA took a dump today. Ouch!Comment
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Still adding on this pullback on BIOD, there's support around $4 ish so that will be my last add. The PDUFA is 10/30 so there are a few weeks for a run up but time's running low.
Some others that I'm looking at: MNKD, CADX, MELA.
ALXA is dead... exactly why I will never hold stock through a decision. The FDA is unpredictable and they seem more clue less than anything. They cited concerns with P1 data but they approved it to P2... makes sense, right?Comment
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DMK
Just curious, what do u know about BIOD? Are they pending FDA approval?Comment
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Yes, they are... Here is some info below from www.fdacalendar.comOriginally posted by wooish View Post
Our lead clinical candidate is VIAject™, a very rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. VIAject™ is comprised of commercially available recombinant human insulin and our proprietary formulation of ingredients, all of which are Generally Regarded As Safe (GRAS) by the FDA. Our proprietary formulation delivers insulin in a form which more closely resembles the way a normal body uses insulin to help glucose enter the body's cells, providing energy that allows the body to function. Currently, insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike. In tests to date, the VIAject™ formulation of insulin promotes a more rapid absorption, which more closely mirrors the effects of naturally produced insulin in non-diabetics thereby providing more effective blood glucose control. This novel therapy is currently undergoing two pivotal Phase III clinical studies. The two studies, one involving 400 patients with Type 1 diabetes and the other involving 400 patients with Type 2 diabetes, are comparing the effects of VIAject™ to Humulin®, the leading recombinant human insulin.Comment
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are you holding through approval or just playing the bounce toward the fda approval date but sell before 10/30?Comment
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Holding biod through the 10/30 is naive. The probability of approval is very small. Their data is inclusive at best.Originally posted by wooish View Post
What biod management is doing is data smoothing and that is not going to work with FDA.
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I've been buying DNDN lately... waitingHide not your talents.
They for use were made.
What's a sundial in the shade?
- Benjamin FranklinComment
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Adding to my position this morning. Will be 66% full after today.Originally posted by peanuts View PostHide not your talents.
They for use were made.
What's a sundial in the shade?
- Benjamin FranklinComment
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VPHM keeps going UP!
Check out what my little old VPHM has been doing.
52 week highs day after day!
Is anyone else here enjoying this ride, and how far will it go?
(I do not want my over-exhuberance to cloud my exit strategy and any feedback here is appreciated!)
-AdamComment
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