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Example of another company that used "old data" in resubmission. Credit to nywest329 on $heff's board
http://www.bizjournals.com/washington/stories/2009/05/04/daily67.html?page=all
Hoping this has another run like the last time it was in the .90's
Ultimately I think $heff and Adam F. will both win. The stock will probably test the mid 70s today. Shorts will win and get a chance to get in lower. Adam may lay off for a while after shorts cover and buy for the inevitable rise in share price. Stock price will rise leading up to Adcom, a win for $heff (and me lol). I am sure Adam will "re-appear" down the line to drive the price back down again.
I wonder what Adam thinks the Panel will recommend? If there is a positive recommendation I do not think Adam will be able to hold this down.
Heb Could this be another possible catalyst? Seems that there is a lot of interest by FDA.
FDA will host a webinar in mid-November on “excellence in advocacy” to advise groups and individuals about common themes that may help them be more effective in working across sectors to accelerate the drug discovery, development and approval process for ME/CFS.
source:
http://www.research1st.com/2012/09/13/fda-opens-dialogue/
CFSAC MEETING Meeting Oct 3-4 (correction)
- I think if the pps does not rebound tomorrow it should next week. I think it is good that we seemed to hold above .80 pretty well today.
www.research1st.com/2012/09/13/fda-opens-dialogue/
http://www.hhs.gov/advcomcfs/
Guess the "shake" is done. Looks like this may have been the last chance to load before decision. Think this may push 6 in the next week or so.
Think there is a good possiblity of early approval with adcom being canceled. Today may have been a good chance to get in.
Contract for wireline east coast.
Friday's volume was almost double the average.
http://www.nasdaq.com/symbol/hptx/historical
Analyst info and old sa article
08-03-12 SA artical
http://seekingalpha.com/article/780201-hyperion-therapeutics-one-stock-i-m-adding-post-ipo
Analyst links
http://www.nasdaq.com/symbol/hptx/analyst-research
http://thestockmarketwatch.com/stock-data.aspx?stock=HPTX&a=showAnalyst
http://www.streetinsider.com/rating_history.php?q=HPTX
http://quotes.wsj.com/HPTX/research-ratings
hptx Pdufa dateis not till January but this has a low float and could move easily.
I am not sure what to expect tomorrow or Monday for that matter. I am going to add a little if it drops 10% and then maybe add more if it drops another 10 % or so. I already have more shares than I planned. It's hard to say where the price will be if approved. However, unlike some recent approvals I think the pps will not fall back to pre-approval levels within days if it does gain approval. GLTA
Norm
finances
The company reported cash and cash equivalents of $7.3 million as of June 30, 2012. Subsequent to the end of the quarter, on July 31, 2012, the company successfully closed its initial public offering and the underwriters exercised their over-allotment option in full raising proceeds, net of underwriter discounts, of $53.5 million. The company intends to use the proceeds primarily for the potential launch of its first drug, Ravicti™ (glycerol phenylbutyrate).
According to Chief Executive Officer, Donald J. Santel, "Having a completed IPO makes us well positioned for the potential approval and launch of Ravicti. We believe Ravicti offers meaningful benefits over the only product currently FDA-approved for the treatment of the most prevalent urea cycle disorders, or UCD. With the Prescription Drug User Fee Act (PDUFA) target action decision date on the New Drug Application for Ravicti now January 23, 2013, we are actively planning for launch, and are looking forward to bringing this important potential new drug to the UCD community."
PDUFA date has been pushed out to Jan 23, 2013
Hyperion Therapeutics Announces Extension of Action Date for Ravicti(TM) NDA to January 23, 2013
5:54p ET September 5, 2012 (Benzinga) Hyperion Therapeutics (NASDAQ: HPTX) announced today that it has received a communication from the U.S. Food and Drug Administration (FDA) extending the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for Ravicti™ (glycerol phenylbutyrate) by three months to January 23, 2013. The FDA extended the action date to provide time for a full review of the submission. Such extensions are standard and are provided for by regulation when additional information is submitted within three months of a PDUFA action date.
About Ravicti™ (glycerol phenylbutyrate)
Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL®, the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders. Ravicti holds orphan product designations in the US and Europe for the maintenance treatment of patients with urea cycle disorders and in the US for the intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.
About Hyperion Therapeutics
Hyperion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of
I have some "stink bids" set real low for tomorrow in case of a bear raid.
Think pps should start to creep back up.
http://www.fool.com/investing/high-growth/2012/08/31/reading-between-the-fda-lines.aspx
split would not satisfy other requirements to get on Nasdaq.
http://www.investopedia.com/ask/answers/121.asp#axzz258xohQF9
Since this is otcb it is my understanding that there would not be halt if news announced during trading hours. Is this reason for pudf date of Aug 10-13? Most likely release being after trading 8-10?
Agreed but a lot of people do not know this
Hoping a positive "SA" article will show up. Think this will move up on its own but it would help.
I think this bear raid came early because there was concern that there may be an early approval, and they would lose their opportunity. Gonna try to grab some cheapies if I can tomorrow.
USA today may have had two different articles ready for publication similar to how newspapers have obituaries set to go for public figures. They may have hit the submit button by mistake lol.
high reward low risk today. If vvus gets a crl or high restictions ARNA is going to be big. Worse case scenario vvus is approved little or no restrictions ARNA goes down 25 percent but will gain this back when we go to market or Europe approval.
a shake, a rattle then we roll
I believe that online auction was for location that they previously announced they were closing?
There is no merger/buy out. The company is exploring options at this time and has hired a company to help them explore these options.
$heff alerted that he sold his position today, this probably had some impact.
Maybe CEO will buy another 5000.00 worth of shares? lol. Still hoping something real will happen though.
Back in for another 20% today hopefully.
Yeah..gotta see if I can get my shares back pre-market. Probably see another 20% tomorrow.
I think it is remarkable that there was no sell off before a long weekend. Wishing I did not a sell half my shares.
Yes I think this has finally bottomed out. (at least I hope it did because I'm done averaging down)
Averaged down and grabbed some .34 today. Thanks for the insight.
Is this price drop due to the potential r/s or from the earnings report?
I guess we know why there have not been any substantial inside buys now.
I was thinking the same thing. Marilyn probably has more shares than him.
a lot of stop losses triggered today. Will go back up over a dollar in by mid morning tomorrow.
I think they had stated in the pr 20 days when the r/s took place.
I expect to see a p.r. coupled with the removal of "d". I bet the company is surprised as I am that the pps has not moved with the recent prs. Then again I may look at the stock price more than them :)