Forum > How do you find beforehand if a stock is close to FDA approval?
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BeretDude

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dr banner said: Bret, your thoughts on ADLS??

 The FDA's advisory board, although it voted positively by a vote of 11-3 that Restanza was safe to take, voted negatively by a vote of 11-3 that the drug was ineffective.  To me, this boils down to a drug being safe to take, but it won't do anything to cure ya. Doesn't sound like something that could take off anything soon, but I have to wonder how many will really delve into the background, or simply react on hearing that the drug is up for FDA approval?  As mentioned above, the advice of the Advisory board is certainly taken into account, but the final decision is still ultimately the FDA's. 

Your decision on how you wish to proceed on this one, but my gut feeling says the FDA won't approve it, but the stock could sure rise before that decision is made, much as it did prior to the news release on June 3rd that the advisory board had negative vibes about it, and the price dropped like a rock. So, based on that, it might possibly be a good time to get into it and plan a quick escape just after it makes the jump up, because if the drug is turned down, the stock will fall hard.   :)

Final thought..  the stock has been making a slow uphill movement since the last big drop and could certainly go higher.  It closed at .60 on Friday with a volume of just over 1 1/2 million, so there is interest there.  As much as I hate to drop back down into Penny Stock land, I do believe it will  track northward, so come Monday I most likely will spend a few pennies on it knowing full well that I will dump it if it does make that sudden jump up just before July 31.  Might be too late after the news......orrrrrrr.. it could get approved and really jump.  I will go with gut and dump.  ;)
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OldFart

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SVNT is stopped pending announcement .....
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russianguy131518

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I wonder why the FDA is always late in it's approvals. First it was HEB and now it's BDSI.
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BeretDude

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BeretDude said: Adding to aforementioned list of drugs up for FDA approval:

ISTA Pharmaceuticals (ISTA)
FDA advisory committee to review Bepreve for the treatment of eye itching    June 26

This stock seems to be flying under the radar for some reason that I couldn't put a finger on.  Maybe someone else will see something I missed about it, but for having announced an FDA NDA meeting on this new drug, I don't see significant interest in it...yet.
Personally, I am not going to let happen what has happened to me the past few trading days and let one slip by.. this puppy is going into my account first thing Monday morning.   ;)

 ISTA  is moving up today,  as is  AUXL, SPPI and AMAG.  I guess we all know how SVNT is doing.. since they got their FDA approval yesterday.  HEB isn't haven't one it's better days, pretty much like most everything else.  All of these drugs were mentioned in this thread.
So far, SVNT is the hot market, but others are preparing to have their day too.   I bought into the ISTA, AUXL, SPPI and BDSI.  Hoping that at least on of them can match SVNT... of the 3, my odds on favorite is BDSI...but any of them could take off.
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buynhold

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Glad I didn't bet against SVNT--shoulda picked up some shares instead, but I'll be happy with what I got.
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BeretDude

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BeretDude said:

BeretDude said:

I bought into the ISTA, AUXL, SPPI and BDSI.  Hoping that at least on of them can match SVNT... of the 3, my odds on favorite is BDSI...but any of them could take off.
I saw that BDSI was down again before the close, so yeahhhhh.. I got some more of it.  Still keepin the faith.  :)
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dr banner

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i'm stocking up on SPPI.
SPPI has two approval dates coming up. 7/2 and 10/8.
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BeretDude

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dr banner said: i'm stocking up on SPPI.
SPPI has two approval dates coming up. 7/2 and 10/8.

 Yes, I bought more SPPI today myself while it was still low..  Good luck  Doc.   ;)
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winslow4

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I was (and still am) in on SVNT, and have plunked down a bit on BDSI today at ~ $6.33.  The interesting thing about FDA approvals for small-mid pharmas and biotechs is that charts, imo, don't matter too much.  It's a straight forward, quasi-binary event.  The drug will either be approved, not approved, or issued an approvable letter.  The first one is great news, the latter two are not so great, but an approvable isn't a kiss of death and usually results in a "rebound" of at least 7.5% if the company is able to make the necessary adjustments the FDA wants to see made.

As far as BDSI, I am pretty confident that it will be approved.  I work in the pharma industry at a contract research organization (we do clinical trials for pharma co's) and have spoken to a few PharmD's that have looked over the drug data/info as well as the news coming out of BDSI.  Given their familiarity with the FDA approval process and the language BDSI has used in recent press releases, it appears it is highly likely an approval will be issued by mid-July.

I'm going to go out on a limb and say that HEB is iffy at best - if you love to gamble it's right up your alley.  I was in HEB earlier this week but bailed today after taking a 10% loss.  If it does get approved then it has potential to go bananas, but if it doesn't....well, it looks like the price per share will be on the way to the basement.

It can be worthwhile to find additional information on specific stocks awaiting approval on the Yahoo finance message boards.  Look around for longs that have been in a while as they will usually have the best grasp of the drug's progress....the SVNT board became absolutely cluttered with junk once it got picked up on all the alerts for its massive gains.  There were a ton of folks flooding it that were just chasing the gains, but were in a bit late to really get the full benefit of the ride up.

That said, my advice is to do some research and come up with a calendar of FDA events (advisory panel meetings, approximate approval decision deadlines) and create a way to receive related news in a place that's easy to use.  I use a Google calendar, tied together with Google reader and finance to set up my iGoogle page to essentially work as a big dashboard.  It shows current headlines, I can glance at stock prices, and keep tabs on upcoming events to research all on one page.
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BeretDude

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winslow4 said:
That said, my advice is to do some research and come up with a calendar of FDA events (advisory panel meetings, approximate approval decision deadlines) and create a way to receive related news in a place that's easy to use.  I use a Google calendar, tied together with Google reader and finance to set up my iGoogle page to essentially work as a big dashboard.  It shows current headlines, I can glance at stock prices, and keep tabs on upcoming events to research all on one page.

 Not sure if you clicked on the first page here,  winslow, but we have a sort of calendar of events for upcoming FDA dates for various drugs.
We may not be Google or Yahoo here, but we TK members do try to keep each other informed.   :)
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winslow4

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BeretDude said:

winslow4 said:
That said, my advice is to do some research and come up with a calendar of FDA events (advisory panel meetings, approximate approval decision deadlines) and create a way to receive related news in a place that's easy to use.  I use a Google calendar, tied together with Google reader and finance to set up my iGoogle page to essentially work as a big dashboard.  It shows current headlines, I can glance at stock prices, and keep tabs on upcoming events to research all on one page.

 Not sure if you clicked on the first page here,  winslow, but we have a sort of calendar of events for upcoming FDA dates for various drugs.
We may not be Google or Yahoo here, but we TK members do try to keep each other informed.   :)
 
Ah, I did see the list on the first page.  I may have a few things to add to it.

ISTA Pharmaceuticals, Inc (ISTA)
Drug/Indication: BEPREVE (bepotastine besilate) ophthalmic solution, 1.5% by ISTA up for Advisory Board Friday June 26
Looks like this one has had a big uptick in the past few days.  I haven't researched this drug, but might be worth looking into.

Matrixx (MTXX)
Drug/Indication: Zicam.  They had 2 of their Zicam products pulled from the market by the FDA.  About a week ago it was trading at ~$19 and now has plummeted to $6.13.  One could potentially catch a gain if it "bounces" a bit.  They have a conference call at 11am this morning regarding the FDA's decision.

ARYx Therapeutics
ARYx Therapeutics (NASDAQ: ARYX) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. 

I believe this study will report that it met its endpoints, which should translate into a modest gain.

I'm at work now, but in a bit I'll try to dig around through the FDA's planned advisory panel meeting schedule to see if there are any more companies to add to the list :)

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BeretDude

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Yes.. ISTA was one of the drugs listed in here.. I bought it..and liking it so far..

I will check out the MTXX.. tks for the tip.    This is what this is all about here.. ;)
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BeretDude

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Agenda
July 28, 2009: Cardiovascular and REnal Drugs Advisory Committee Meeting Announcement

The committee will discuss new drug application (NDA) 22-449, binodenoson injectable, lyophilized solid 250 micrograms vial, King Pharmaceuticals Research and Development, Inc., for the proposed indication: Short acting coronary vasodilator for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease.


Just thought I would add this... it wasn't on the list prior... trading symbol is KG
Also a reminder that tomorrow (June 26) is the FDA review board meeting on ISTA.

Happy Trading   :)

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BeretDude

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dr banner said: OK so here is the basic list that i have for the year 2009.

Savient Pharmaceuticals
Drug/indication: Krystexxa for gout
FDA advisory panel date: June 16
FDA decision date: Aug. 1

BioDelivery Sciences
Drug/indication: Onsolis for breakthrough cancer pain
FDA decision date: June 15

Spectrum Pharmaceuticals
Drug/indication: Zevalin for non-Hodgkin's lymphoma
FDA decision date: July 2

Labopharm
Drug/indication: DDS-04A for depression
FDA decision date: July 18

United Therapeutics
Drug/indication: Tyvaso for pulmonary arterial hypertension
FDA decision date: July 30

Advanced Life Sciences
Drug/indication: Restanza for community-acquired pneumonia
FDA decision date: July 31

NeurogesX
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16

Allos Therapeutics
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24

Amgen
Drug/indication: Denosumab for osteoporosis
FDA decision date: Oct. 19

Acorda Therapeutics
Drug/indication: Fampridine for multiple sclerosis

GTx
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30

Vion Pharmaceuticals
Drug/indication: Onrigin for acute myelogenous leukemia
FDA decision date: Dec. 12

 Doc?   Where did you get your dates from?  The following is taken from the FDA's Advisory Committee calendar for July, and I don't see any of your July ones on it?   And you will have to go to the  FDA site to see it, because in Preview, when I clicked on the links below, I got a 'Jumpin Jiminy'...  :)
I think this link works though...  hopin anyway...  http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

July 2009

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Anything going to pannel review is a great thing... The pannel results are viewable and you can see the results... There is a open transparency drive going on with the FDA... Email: Transparency.Meeting@fda.hhs.gov  Please send an email to the agency for transparency about dates, extentions, results, etc... There is also a meeting that took place... It's refered to in the FDA website somewhere... It helps to understand some of the issues surrounding the FDA and it's ability to share information to the stock holders.
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BeretDude said:

dr banner said: OK so here is the basic list that i have for the year 2009.

Savient Pharmaceuticals
Drug/indication: Krystexxa for gout
FDA advisory panel date: June 16
FDA decision date: Aug. 1

BioDelivery Sciences
Drug/indication: Onsolis for breakthrough cancer pain
FDA decision date: June 15

Spectrum Pharmaceuticals
Drug/indication: Zevalin for non-Hodgkin's lymphoma
FDA decision date: July 2

Labopharm
Drug/indication: DDS-04A for depression
FDA decision date: July 18

United Therapeutics
Drug/indication: Tyvaso for pulmonary arterial hypertension
FDA decision date: July 30

Advanced Life Sciences
Drug/indication: Restanza for community-acquired pneumonia
FDA decision date: July 31

NeurogesX
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16

Allos Therapeutics
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24

Amgen
Drug/indication: Denosumab for osteoporosis
FDA decision date: Oct. 19

Acorda Therapeutics
Drug/indication: Fampridine for multiple sclerosis

GTx
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30

Vion Pharmaceuticals
Drug/indication: Onrigin for acute myelogenous leukemia
FDA decision date: Dec. 12

 Doc?   Where did you get your dates from?  The following is taken from the FDA's Advisory Committee calendar for July, and I don't see any of your July ones on it?   And you will have to go to the  FDA site to see it, because in Preview, when I clicked on the links below, I got a 'Jumpin Jiminy'...  :)
I think this link works though...  hopin anyway...  http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

July 2009

hey Beret
Well my list for July looks like they are for "FDA decision dates" while the links you have look like  "FDA advisory panel dates". I got the list of dates from an article from yahoo finance or something. i forget.

Good Luck with ISTA. i'm hoping for some good news. I still have my fingers crossed for SPPI.
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dr banner said: OK so here is the basic list that i have for the year 2009.

Savient Pharmaceuticals
Drug/indication: Krystexxa for gout
FDA advisory panel date: June 16
FDA decision date: Aug. 1

BioDelivery Sciences
Drug/indication: Onsolis for breakthrough cancer pain
FDA decision date: June 15

Spectrum Pharmaceuticals
Drug/indication: Zevalin for non-Hodgkin's lymphoma
FDA decision date: July 2

Labopharm
Drug/indication: DDS-04A for depression
FDA decision date: July 18

United Therapeutics
Drug/indication: Tyvaso for pulmonary arterial hypertension
FDA decision date: July 30

Advanced Life Sciences
Drug/indication: Restanza for community-acquired pneumonia
FDA decision date: July 31

NeurogesX
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16

Allos Therapeutics
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24

Amgen
Drug/indication: Denosumab for osteoporosis
FDA decision date: Oct. 19

Acorda Therapeutics
Drug/indication: Fampridine for multiple sclerosis

GTx
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30

Vion Pharmaceuticals
Drug/indication: Onrigin for acute myelogenous leukemia
FDA decision date: Dec. 12



How or where did you find this info???

 
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BeretDude

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dr banner said:

hey Beret
Well my list for July looks like they are for "FDA decision dates" while the links you have look like  "FDA advisory panel dates". I got the list of dates from an article from yahoo finance or something. i forget.

Good Luck with ISTA. i'm hoping for some good news. I still have my fingers crossed for SPPI.

 
Trading has been halted on ISTA  ..  the FDA said their drug was safe and effective.....more to come...
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ISTA: Trading currently 1:54 Central at open price... Up over 5 on the news.... No buyers.... Priced at 5.00 by Analysts.... may strike tommorrow... but no buyers to speak of...
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ISTA  and SPPI had a great day today. curious to see what happens monday