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CPRX 1.47 + .09 Folks trying to get in before the bell at $1.50. Exciting news today.
CPRX 1.46 + .07 up on 2 articles:
Motley Fool:
http://beta.fool.com/nedsway/2013/08/11/why-catalyst-pharmaceutical-partners-is-rising-on/43225/
Seeking Alpha:
http://seekingalpha.com/article/1630982-catalysts-pharmaceuticals-primed-for-an-easy-double-for-2h-of-2013
NVO...$160.92 FDA Advisory Committee meeting on November 8th, 2012...
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm323208.htm
1 Year chart looks terrific.
OT:Drug Review Steps Simplified
1.Preclinical (animal) testing.
2.An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3.Phase 1 studies (typically involve 20 to 80 people).
4.Phase 2 studies (typically involve a few dozen to about 300 people).
5.Phase 3 studies (typically involve several hundred to about 3,000 people).
6.The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7.Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8.After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. This is when the PDUFA (Prescription Drug User Fee Act) date is set. Standard review period is 10 months and the expedited review period is 6 months (reserved for first in class or critical drugs).
9.If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10.The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
11.The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12.FDA reviewers will approve the application or issue a complete response letter.
Each step of this process can act as a catalyst for a biotech stock. Phase 2 and 3 study results tend to carry a good amount of weight in the market. Once the NDA has been accepted and filed, attention turns to the PDUFA date, which is the end of the 10 or 6 month review period. For some drugs a review panel is assembled by the FDA to provide additional advise toward approval of a drug. The FDA does not always follow the advise of this panel, but it's typically a good indication of the probability of approval. The review panel vote often carries a large amount of weight in the market (see ARNA 5/10/12). Of course the date of approval has the biggest effect on market value.
taken from BSP Biotech Stock Tracker
HEB $.81...It will be soon enough. Sometimes it can be difficult, but patience is how we make money on this board.
HEB is unique in that it has 2 catalysts lined up that should see movement in the share price:
December 20th, 2012, and February 2nd, 2013.
Regardless of the results of the FDA's decision regarding AMPLIGEN, investors are going to be very interested in the stock.
For patients that are suffering from CFS, AMPLIGEN is the only promising drug out there in the short term that can treat this bothersome disease. No other drugs or clinical trials involving treatment for CFS are out there that are even close to nearing completion, nevermind any phaseIII clinical trials that to my knowledge are showing the promise that AMPLIGEN has brought to sufferers.
With those factors in mind, we should begin to see a jump in the share price as NEWS regarding approval nears, and the speculations begin.
Remember too, that the market doesn't lie. The stock has shot up from around $.30 in July to over $1.00 recently, simply based on the momentum speculation on AMPLIGEN has brought to the table, so no doubt you are going to see a temporary drop before the real buying begins.
There is no doubt in my mind that we will see new 52 week highs as February 2nd nears, perhaps even before then after the meeting on December 20th. Patience my friend...
Forgive me for my memory not being so spry, but was the alert on $heff's board?
SRPT $42.17... Folks, this is a true millionaire maker today. For those that bought this when $heff alerted this almost $30 ago, congratulations...especially for those that waited.
Regardless of the money we are making on this play as investors, this is truly a milestone for families that have had to deal with this terrible disease without a light at the end of a tunnel. Wonderful news!
I hope all of us give $heff credit for calling this wayyy BEFORE ANYONE ELSE:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78943709&txt2find=srpt
Excellent article... As $heff said in an earlier post, we all hope that the FDA can find a way to get this drug into the hands of CFS patients as there isn't much to offer for the next few years. I know that we are eagerly awaiting approval for many of our patients.
It is interesting to see how those that don't need the drug have such a different perspective on the approval process than those that are going to be personally affected on a physiological level. This disease is serious and affects a person in more ways than is often mentioned.
Just as most folks don't discuss or mention how PAINFUL cancer can be, alot of the effects of CFS go unmentioned usually because the overwhelming weakness that affects alot of CFS sufferers is so dramatic. We desperately need a drug like Ampligen.
[i]HEB, in my opinion, will recover from all of the negative articles lately, simply because of this fact.
Thanks. I hope everyone here gives $heff the credit he deserves.
Before I found this board, I really never took notice of how biotechs performed. The information here has been such an enormous help to me personally as well as to my portfolio.
I am not trying to speak for $heff, but I think that that is one of the reasons he has this board...to make alot more investors out there become INFORMED investors, not just a bunch of folks that are blindly buying PUMP and DUMPS or risking a ton of their cash on the recommendation of some schmuck that claims to have the next millionaire making stock.
I truly believe that we can all make our financial dreams a reality following $heff's "doubles and triples, not just home runs" strategy, and when you look at the numbers, it would be a mistake to NOT follow this strategy.
For example, look at $heff's portfolio. If you were to go to any brokerage and ask a "financial advisor" if they could take $3600 and turn it into over $2,000,0000 in about 2 years, they would spit their coffee in your face in pure shock(I know, bad visual, lol), but that is exactly what $heff has done. Remember, that kind of a return makes Warren Buffett's track record look laughable!
What's even more admirable, is that this has all been done without him ever focusing on stocks that would not benefit his followers FIRST...something that you just don't see very often.
It is also refreshing for $heff to allow people with different viewpoints to have a voice here on his board as well, which in itself says alot about how confident and informed $heff is when he decided to alert us about a stock he has invested in.
Just look at all the drama that was going on today with HEB. All of us on here know that regardless of whether you believe that the FDA will or wont approve AMPLIGEN, having 2 near term catalysts will undoubtedly make this stock move.
And, as the price being fairly stationary has shown (IMO, it could have fallen ALOT more), INFORMED investors know when something has value and when something doesn't...regardless of whether there is a negative opinion by someone or a group, or not.
Like $heff says, the market doesn't lie, and that is all that matters when it boils down to it.
Once again, my heartfelt thanks, $heff!!!
At times, I put in more of my own money into my portfolio to invest, but the vast majority of my gains are from the stocks found on this board...=)
HEB $.81... Added 100,000 shares. Solid double catalyst play, December 20th, 2012 and February 2nd, 2013 should push this alot higher.
Temporary dip here is an excellent opportunity for us here on the board to load up even more.
The fact that it is holding it's ground in the .80's is a very good sign, in my opinion.
SIDE NOTE: I just wanted to reiterate my appreciation for what $heff has done with this board, and especially for my portfolio. On January 1st, 2012, my portfolio started with around $3,000 and I then, based on $heff's board,bought and sold the following (in no particular order):
VVUS,ARNA,TLON,RNN,HEB,AEZS,GNOM,PLX,ACAD,ALXA,ASTX... My portfolio stands right now close to $300,000.
I FOLLOW $heff, and NOONE else.
Do your own DD on the stocks that are mentioned here, and in my opinion, you will not find a better board anywhere on the net.
HEB, someone did the same thing on level 2...
Somebody that isn't too bright sold this wayyyy too early. Look at level 2...
CYTK..$.90 I think this is the next ACAD for us here at the station. Those of us looking for the sub dollar gold mines should take a good look at this one.
HEB..$.80 My sources confirming FDA panel on December 20th, resulting in 2 catalysts for this stock, which might be the reason for the gains last couple months (stock was sitting at .30 back in July).
Lots of room to grow here. This catalyst on December 20th, plus the PDUFA for Ampligen on February 2nd, 2013 makes for a highly attractive double catalyst. Should be very interesting next few days...
AEZS..$.70 Sold all shares after an entry of $.48 (average) for a 70% gain. Fast track approval might send this one even higher, but locking in profit is key with some of these bio's. Another great play courtesy of $heff! Thanks again, $heff!!!
AEZS...$.67 For those that haven't got in yet, you still have time. FDA decision on September 24th is major catalyst for this stock and it has plenty of room to grow.
AEZS $...67 and climbing. This has definately got room to grow here as it competes with HEB as $heff's other "lotto" play. Another great trade for us here at the station!
AEZS$.64 For those that haven't got in yet, you still have some time. FDA decision between now and September 24th is a major catalyst for this stock.
AEZS $.58 Starting to fly.
AEZS Absolutely! This will continue to build steam as we get closer to the FDA's Fast Track decision by September 24th. All signs point to a breakout...courtesy of $heff!
AEZS $.55 Another green day as we head toward the end of a profitable week for us here on the board. This will be an exciting one in the coming days, replicating $heff's other lotto pick, HEB. Consensus is showing that it should.
ACAD- Great info, $heff. I think we break the 52 week high of 2.30 as the catalyst draws closer.
OT: For those that can, please donate to biopharmacatalyst.com
It is a fantastic site and has helped many of us here at the station. Any amount will be appreciated.
I agree. Just be patient, the profit taking from HEB should result in some buying of AEZS. This is what smart traders like us here at the station try to do.
There is alot of room to grow with AEZS. I think it will do very well, same as HEB.
I bought HEB at .33, but I havent sold all of it yet, because there are still catalysts left to come that will push this one even higher, IMO.
I like how AEZS is churning, and believe it will begin moving now that profit taking has begun with $heff's other lotto pick, HEB.
HEB, one LOTTO down, one to go in AEZS. Time for us to put some of that HEB profit into AEZS. With this great group we have here, $heff, AEZS should do just as well if not better than HEB.
RNN News due tomorrow regarding its earnings as well as positive phase II trial results for ARCHEXIN to treat pancreatic cancer.
Been holding for a while, not trading the ups and downs because I have a vested personal interest in the disease this drug will be able to treat once approved.
I bought in at .32, and I still think we should be well over $1.00 with positive news. We shall see.
RNN $.49 Company announcing results from it's phase II trial of ARCHEXIN for pancreatic cancer set for August 6th. Been trading sideways the last few trading sessions, hovering around .50.
This should begin to move higher in anticipation of positive results, which seem very likely based on the information available.
Great entry point folks here on the board for those that aren't in yet, being as that this stock seems to move on no news, as evidenced by a few weeks back5 when it soared from .35 to .80 in a few days.
Hoping to have a similar bounce here in the next couple days...
RNN $.49 Company announcing results from it's phase II trial of ARCHEXIN for pancreatic cancer set for August 6th. Been trading sideways the last few trading sessions, hovering around .50.
This should begin to move higher in anticipation of positive results, which seem very likely based on the information available.
Great entry point folks here on the board for those that aren't in yet, being as that this stock seems to move on no news, as evidenced by a few weeks back5 when it soared from .35 to .80 in a few days.
Hoping to have a similar bounce here in the next couple days...
OT: Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients
FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations.
OT: Sally Ride Dies
http://www.timesunion.com/news/article/Former-astronaut-Sally-Ride-3729120.php#photo-3231154
Perhaps RNN's Archexin will help victims of this terrible disease.
Truly a sad day for America. A true pioneer.
RNN $.50 + $.02 For a stock under $1.00, this should continue to appreciate in value once positive results come in this quarter. I would hope for at least $1.50 short term, maybe more, being as that this is the first ever drug of its kind for pancreatic cancer (ARCHEXIN).
Down the line, with FDA approval, I wouldn't be surprised at the closer to $10 range, but probably a buyout more likely. Just my thoughts and opinions...
I am wondering how much we appreciate in value once positive results come in this quarter. I would hope for at least $1.50 short term, maybe more, being as that this is the first ever drug of its kind for pancreatic cancer (ARCHEXIN).
Down the line, with FDA approval, I wouldn't be surprised at the $5 to $8 range, but probably a buyout more likely. Just my thoughts and opinions...
PSTI $3.32 + .63 Scott Matusow's new biotech pick:
http://seekingalpha.com/author/scott-matusow/stocktalk
Great trade, $heff! That didn't take long to get over $1.00!
RNN $.50 + .09 Nice bounce back after yesterday's selloff. I am still in this one, eagerly anticipating release of Phase II results of ARCHEXIN, which are scheduled for Q3 2012.
Today's gain also shows how easily this stock can fly with little action, while also remaining under the radar.
The clinical trial is scheduled to end this month:
http://clinicaltrials.gov/ct2/show/NCT01028495?term=Rexahn&rank=4
So far, according to my sources, results have been amazing. Good news for those suffering from a deadly disease without any effective treatment.
http://www.rexahn.com/cms/index.php/2012/05/rexahn-pharmaceuticals-submits-archexin-phase-ii-protocol-for-ovarian-cancer-to-fda/
OT: iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements: Recall - Possible Salmonella Contamination
Sedona Labs today announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination. As a result,Sedona Labs is now voluntarily recalling certain lots of iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder distributed between 3/16/2011 and 5/3/2012.
http://www.drugs.com/fda/iflora-kids-multi-probiotic-iflora-4-kids-powder-dietary-supplements-recall-possible-salmonella-13146.html
Excellent catch $heff! Wasn't expecting this to be in play till early next year, next quarter at the earliest.
This one should definitely soar in the coming days or weeks leading up to positive news from the phase IIb study. Early release of data is a great sign!
RNN $.57 Yesterday's profit taking session hasn't held it back today.Great chance to get in at a low price if you missed the last run over the last few days.
Should continue to rise as ARCHEXIN continues to show positive results according to my sources as we inch closer to the company's Phase II data release.