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[stock926]

Labopharm

DDS.TO/DDSS

FDA Approval date: July 18

Note: Analyst Claude Camire stated that it has a 80%
chance at getting approval for "Tramadol"


I think thats a pretty good sign that it will be approved tomorrow.

for those of you who aren't already in the baby... watch in this weekend and on monday morning... you might be able to profit of it.

good luck trading guys!

[dorkytom]

Perhaps this doesn't need to be said.... but I've been seeing a lot of people recommend stocks using the 80% chance of approval (sometimes it is even claimed by CEOs, for example HEB) I feel it is often used out of context and in some cases duping those that are unfamiliar with Pharma stocks.

I'm not questioning the chances of approval for Labopharm... I'm not very familiar with the company except for quick skims through their posterboards (I have no position neither short nor long). It may very well be 80% or even greater... perhaps this is maybe an inappropriate location for me to warn people about this claim, but I hope it will encourage people to do DD rather than rely simply on this claim to buy stocks... Also i am not questioning stock926's DD, it maybe very extensive, but I'm not a fan of posting a buy recommendation and simply having the 80% claim as the reasoning

The statistic is approximately 80% of drugs that get through Phase1/2/3 trials and file an NDA EVENTUALLY obtain approval... meaning it is not an 80% chance that any drug will get approval on the current attempt.

See Page 16
http://oversight.house.gov/documents...4529-73424.pdf


The typical first-cycle approval rate is actually less than 50% . (I don't even know what try this is for LaboPharm.. I think its first, which is why I'm stating that I'm not trying to diminish the value of this stock)

I should note that certain designations/types of drugs do have much higher first cycle approval rates see the link for more information.

This is a link about first cycle approvals to help substantiate my warning see the Executive Summary if you don't want to read the whole thing.
http://www.fda.gov/downloads/AboutFD.../UCM109756.pdf

Anyways thanks for listening to my Rant.

BTW I'm long on HEB, which made the same claim...

I apologize in advance to you Stock926 if it appears I'm trying to bash you.

[stock926]

Originally Posted by dorkytom Perhaps this doesn't need to be said.... but I've been seeing a lot of people recommend stocks using the 80% chance of approval (sometimes it is even claimed by CEOs, for example HEB) I feel it is often used out of context and in some cases duping those that are unfamiliar with Pharma stocks. I'm not questioning the chances of approval for Labopharm... I'm not very familiar with the company except for quick skims throught they're posterboards. It may very well be 80% or even greater... perhaps this is maybe an inappropriate location for me to warn people about this claim, but I hope it will encourage people to do DD rather than rely simply on this claim to buy stocks... Also i am not questioning stock926's DD, it maybe very extensive, but I'm not a fan of posting a buy recommendation and simply having the 80% claim as your reasoning This statistic is approximately 80% of drugs that get through Phase1/2/3 trials and file an NDA EVENTUALLY obtain approval... meaning it is not an 80% chance that any drug will get approval on the current attempt. See Page 16 http://oversight.house.gov/documents...4529-73424.pdf The typical first-cycle approval rate is actually less than 50% . (I don't even know what try this is for LaboPharm, which is why I'm stating not trying to diminish the value of this stock) This is a link about first cycle approvals to help substantiate my warning see the Executive Summary if you don't want to read the whole thing. http://www.fda.gov/downloads/AboutFD.../UCM109756.pdf Anyways thanks for listening to my Rant. BTW I'm long on HEB, which made the same claim... I apologize in advance to you Stock926 if it appears I'm trying to bash you.

No thank you! you gave me a different perspective for me to look at.

Again i am speculating about this stock but the 80% chance recommendation came from an analyst.

Im not sure that he is fully credible but i just wanted to share that in case nobody knew.

Again thx for your "rant"... it was very interesting =)

[PharmstockGuru]

Hello Guys,
I have a bachelors degree in Health Communications with pharmaceutical emphasis from GVSU, so naturally pharmaceutical companies interest me and as a result my portfolio is only biotech and pharmaceutical companies. Labopharm's phase III clinical data is key to look at.

"DDS-04A is designed to address patient needs in the current antidepressant landscape, providing an effective and convenient treatment option. In a Phase III placebo-controlled clinical study, DDS-04A demonstrated:

* Antidepressive efficacy:
o Statistically significant improvement on the Hamilton Depression Rating Scale (HAMD) from baseline to end study
o Rapid onset of action. Statistically significant improvement in HAMD scores within one week after treatment initiation
o Greater HAMD responder rate by 2 weeks of treatment
* Improved overall sleep quality
* Well-tolerated adverse event profile:
o Transient mild to moderate somnolence
o Incidence of insomnia, anxiety, agitation, and weight change not different from placebo
o Very low rate of sexual dysfunction"

These are great reductions in side affects, 40-50% of people don't use the medication because of how poor the side affects are. A reduction in them is only beneficial toward the adl's (activities of daily living). My bet on this drug is the FDA will approve it, after all the phase III results are some of the better results I have seen in a while.

[stock926]

Does anyone know what time during the day that the FDA releases their decision on whether or not this drug gets the approval?

It is supposed to be today July 18, 2009 but what time?

anybody know?

Thx for the help!

[R MAN AUDIO]

Originally Posted by stock926 Does anyone know what time during the day that the FDA releases their decision on whether or not this drug gets the approval? It is supposed to be today July 18, 2009 but what time? anybody know? Thx for the help!

I dont see the FDA releasing today.....I would say, if they have come up with a decision, it would be release monday morning.

I hope this gets approved, I cant afford to lose more money!

[stock926]

Originally Posted by R MAN AUDIO I dont see the FDA releasing today.....I would say, if they have come up with a decision, it would be release monday morning. I hope this gets approved, I cant afford to lose more money!

you have a long position too eh? good luck to both of us!

thx for the info... now im gonna be on edge the entire weekend lol

[R MAN AUDIO]

Originally Posted by stock926 you have a long position too eh? good luck to both of us! thx for the info... now im gonna be on edge the entire weekend lol

Ya...I have long on DDS.TO, NEPH, HEB and SOMX....so far im even as some are up and some are down...but if one or more get declined, im gonna lose a lot of money....have about $30K invested in the 4 and am hoping for 3 out of 4 to get approved and bounce high....otherwise im gonna give up on the pharmy plays and move back into financials and other stocks moved by the DOW.

[OppressedWriter]

Here's my 50 day chart... Read it as you will, if the market remains in an uptrend this is probably a decent buying opportunity, oversold, and way below trend line.

[stock926]

Originally Posted by OppressedWriter Here's my 50 day chart... Read it as you will, if the market remains in an uptrend this is probably a decent buying opportunity, oversold, and way below trend line.

Hey OppressedWriter where did you get this tech charting program? is it free or did you have to buy it?