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NEOP Question?
Still without internet in much of AL and 3g is being slow to surf net, was it reported that NEOP is presenting at conference this week? and is it possible lymphoseek data release or is it scheduled for other topics? thanks guys
NEOP - holding nicely at the moment. Still want to watch it closely for awhile though.
Very high volume from AVNR on Thursday. 16.8 m traded and avg is 4m a day. I was lucky enough to buy some calls in the morning that closed the day up 40%. Lots of short interest in this one so maybe the move was attributed to shorts closing positions. Some are anticipating script #'s from Nuedexta to be released in May so maybe some shorts didn't want to risk good numbers or maybe a lot of longs coming in expecting good numbers.
Not really a defined catalyst here so I am skeptical to take much of a position but I will keep an eye on it this week. I like Nuedexta sales long term but I don't know that many scripts have been written in such a short time after launch. Some of the numbers being reported from AF are on par with expectations but it will all come down to how market views the data when released.
I'm in with just 20 September $3.50 calls @ 0.60
I don't think they have given an exact day. I believe they just said topline data to be released in May and full release early June.
PCRX is an interesting play with upcoming catalyst. New stock with very low volume and no options yet. VERY low float - anyone looking at this for possible runup candidate? The volume bothers me but at the same time that and the low float could also be an advantage if stock moves north. Thoughts?
I agree newtostocks. I am a bit disappointed because I was looking for results sooner. But my cost average is low $3's plus some October calls so I can handle this dip. I still think results will be great so I will wait it out. Showing some strength in 3.80-3.85 range for almost an hour now. Hopefully it can avoid a late day sell off and I'll be content.
Invest12: I don't follow them closely but this was from their last report:
CK-2017357
Cytokinetics plans to present data from the Phase IIa EoE clinical trial of CK-2017357 in ALS patients during a Plenary Session at the 63rd Annual Meeting of the American Academy of Neurology in April in Honolulu, Hawaii.
Cytokinetics anticipates that, in the first half of 2011, data will be available from the ongoing Phase IIa EoE clinical trial of CK-2017357 in patients with symptoms of claudication associated with peripheral artery disease.
Cytokinetics anticipates initiating, in the first half of 2011, a Phase I drug-drug interaction study of CK-2017357 administered orally to healthy volunteers. This study is intended to evaluate the effects of CK-2017357 on the pharmacokinetics of riluzole and other drugs and the pharmacokinetics of CK-2017357 when administered after a meal and when fasting.
Cytokinetics anticipates initiating a Phase II multi-dose, safety, tolerability, pharmacokinetic and pharmacodynamic clinical trial of CK-2017357 in patients with ALS. This trial, which may begin in mid-year 2011 following the availability of data from the riluzole arm of the Phase I drug-drug interaction study, is expected to evaluate patients receiving daily oral doses of CK-2017357 for 10 to 14 days.
Cytokinetics anticipates that, by the end of 2011, data will be available from the ongoing Phase IIa EoE clinical trial of CK-2017357 in patients with generalized myasthenia gravis.
CK-2066260
Cytokinetics anticipates filing an Investigational New Drug Application (IND) for CK-2066260, a potential drug candidate from its skeletal muscle contractility program, by mid-year 2011.
Cytokinetics anticipates initiating a first-in-humans Phase I clinical trial of CK-2066260 in healthy volunteers in the second half of 2011.
Thanks barefoot. It doesn't look like they will raise immediately. Maybe sometime in the future but I'm only concerned with anything in the next 1-2 months. It would make more sense to sell shares after PPS increases (potential) after lymphoseek NDA/data anyways...or at least in my mind.
It was in the tripoint global research report that total sales estimated around $373m as per the company - tripoint thought this was conservative. That report came out last September and since then most have used the 450m number. But in the tripoint report...they break the $373 number down.... (1) US - 150m (2) Europe - 62m (3) ROW - 151m
Here is that report:
http://www.tripointglobalresearch.com/research/NEOP/NEOP_Report_092210.pdf
NEOP - I got back in this week average of 3.11 which is looking like a good move so far. Looking at Lymphoseek data it seems very likely that results will be promising. But does anyone have any issue with their cash on hand? I'd have to check their 10-k to get their exact burn rate and data but if i remember correctly they don't have a lot of cash at the moment. I'm hoping we can get to trial results without seeing any cash raising activity. Thoughts???
-JRB
Color: have you taken a look at OPTR? I had it on watch at 11.30ish
and like the way it trades but that FDA panel early April bothers me and I don't know if it will be best to wait until after to get in a position. Gekko put out some data recently showing that more often than not those panels have negative effect on price atleast in short term until it recovers leading into pdufa.
Options question: I wrote some covered calls on SPPI @ $8 awhile back. I've done this before but never has the price reached the strike point. SPPI reached $8 for awhile today - but my account shows I still have all my shares. I assumed if the purchaser exercised the contract when SPPI was over $8 my shares would have left my account at that time? Is it safe to say I still have my shares or will I not know until Friday's option expiration??? All this assuming that SPPI doesn't reach $8 again before Friday again...although it looks like it will do so.
Thanks!
SPPI was mentioned on CRAMER tonight...
http://www.cnbc.com/id/42076432?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
not a huge fan of his - but this may help keep the volume up.
I was looking to take some off the table and play some solars or natural gas plays due to situation in japan but now i'll wait and see if SPPI can break $8 tmrw.
I knew earnings would be good but I didn't expect this kind of jump. I thought most were already aware of what kind of #'s would be posted. Looking forward to conference call. This gives good momentum heading into April hopefully.
Pcrutch - Do you think this significant for SPPI as far as Q1 sales or is this a non-issue??
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM246065.pdf
SPPI News out.....
This was updated today..
From the FDA website...
"Due to the shortage of both leucovorin and levoleucovorin products, the FDA has utilized regulatory enforcement discretion for Spectrum Pharmaceuticals, Inc. to temporarily import levoleucovorin 100 mg Powder for Injection manufactured by Pfizer Inc. "
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
Anyone following PTIE here? Been keeping an eye on it lately. Not many PDUFA dates scheduled for April-July. I figured most would be jumping in SPPI and PTIE soon. Haven't taken a position yet but it looks like it could have run-up potential.
SPPI - presenting at the Global Health Care Investor Conference in the morning - 8:30 ET - available for streaming through their website. Many other companies presenting as well.
A claim of superiority would have given them better chance at market share given the cost issue. Hopefully the market feels good about chances of success in April and we get some movement before then. The company must feel confident in their data or else they wouldve had more trials-unless cost was an issue?
Anyone have any clue as to why Spectrum (SPPI) could not show that Fusilev was non-inferior to leucovorin back in 2009. I know the FDA did not require additional studies - and it has been used overseas for years. It would seem like they should have had enough data at the time, and since there have been no more studies, what has changed???
I couldn't find any posts that were more specific about what the FDA said in 2009.
The market for colorectal cancer has huge potential if they could get approved. Tons of cash, very little debt, and other approved drugs...SPPI is in a great position if they could get a thumbs up on this.
-JB
SPPI info
Full financial results will be released within 2 weeks. This is a quick rundown of the what earnings are expected to look like:
In 2009 for the year:
38 mil total revenue
28.2 of that was product sales
For 2010:
73 mil total revenue
60 from product sales
Here's a rundown of the first 3 Q's PRODUCT REVENUE only:
1st Q: Product Revenue of 7.1: Zevalin = 6.5 Fusilev = 0.6
2nd Q: Product Revenue of 9.3: Zevalin = 6.9 Fusilev = 2.4
3rd Q: Product Revenue of 13.7: Zevalin = 7.7 Fusilev = 6.0
4th Q: Product Revenue of 30: Details unknown yet
Cash on hand = 104 mil
AEZS has a couple of presentations on monday - stock has been trading well lately.
SPPI is my largest holding as of now. I think it will get over the $7 mark again soon.
PLX decision expected today GLTA - MY portfolio needs an approval after the bashing SPPI has taken this week. Hopefully SPPI will rebound going into their PDUFA. Still a positive week - picked up some NEOP at $3.71 that is balancing out my SPPI loss but still was not expecting that much of a dip. Hopefully it's just visiting its 20/50 DMA and will bounce.
This is good news. Although the Cerezyme supply has been corrected the ability to switchover is VITAL to success of UPLYSO because the market has been exposed to Cerezyme for some time. This allows Protalix to not just limit their market to new patients but to those already using Cerezyme. It is always a challenge to break into an established market but with the results from the switchover trial, at least they aren't "behind the 8-ball" so to speak and all patients are potentially up for grabs. Sales will depend on PLX developing an effective market plan - as all the data/safety results seem on par, if not slightly better is some aspects, with competitors.
Good luck to all!
Disclosure: I am holding a small position in PLX and will be holding through the decision.
just click this link
http://investorshub.advfn.com/boards/addBrdMrk.asp?board_id=16083
FDA question -
In terms of PLX and others who had potential "manufacturing" issues - what exactly is required for approval? Does the FDA have items listed anywhere?
Thanx
PTIE - Pain Therapeutics, Inc.
Anyone playing this one? FDA accepted their resubmission for pain drug - REMOXY - decision set for JUNE 23. Received a CRL but had a 11-8 positive panel vote.
Good article here about approval rates
http://finance.yahoo.com/news/Cell-Therapeutics-and-Ariad-iw-3502820221.html?x=0&.v=1
Didn't see the Cramer piece but many others have been saying that lately. Here's a link from Reuters:
http://www.reuters.com/article/2011/02/10/pharmaceuticals-rd-idUSLDE71912R20110210
It seems clear that if they aren't going to spend for R&D they are going to have to acquire companies who have been doing the work- or else their product lines will disappear and they cannot compete.
Got out of NEOP today - still think it has a great future but I was concerned with the amount of time left before trial results in early Q2. When I bought I thought the results were expected first week of March or so. Didn't want to see my profits linger away a few cents a day for a month. Had over 50% of my account in play here so I was extra careful once I saw how it was trading this morning - sold at 3.70 and the rest at 3.80 when it popped back up. May buy back before results depending on price action.
Lymphoseek has had great results thus far - definitely see myself getting back in if they get NDA acceptance and PDUFA in 4Q or 1Q '12. Also have other products in pipeline.
Picked up SPPI this morning at $6.99. I also considered buying PLX before their date next week. The consensus seems to be they have great odds for approval - but with no gains locked in already I think the risk/reward may be a little too high for me.
GLTA
Thanks that is good info.
It seems most people say results in Q2 - is there any more specific time frame or is that all we have to go on?
I like the LDL-C levels compared to Lovaza.
AMRN beginner question:
Just started looking into AMRN this evening. Trying to decide whether it is a better buy than SPPI. The ANCHOR results are out Q2 and I know there is a lot of talk of acquisition. Are there any other catalyst upcoming or does that about cover it?
Wish I would've taken your advice here.
Great play. Looking to shed a portion of my NEOP from 2.67 entry tmrw or friday. Hoping I'm not too late for SPPI run. I hate missing the initial jump. =/ It was in the low-mid $6's for a long time. I should've took a starter position to hedge risk. Playing options seems to be the way to go for PDUFA dates. I've never done it for trial results or any other type of catalyst but with FDA approvals it seems to be a successful play most of the time.
All NEOP investors should listen to this:
http://media.bloomberg.com/bb/avfile/vduaMCKvWmy4.mp3
I'm still holding NEOP from $2.67 entry - plan on holding until test results. Should have positive results due hopefully by first week in march - filing NDA soon after
ColorofMoney: Yesterday was AVNR annual shareholder meeting.
A few guys went and posted some very good information on the Yahoo AVNR board. Way too much to copy and paste here but you should check it out if you haven't. Theres two really good posts, easy to find because they've had 50 or so replies. Usually take everything on yahoo boards with a grain of salt - but more than one person summarized and had same information so it is apparently legit.
Important points if you don't feel like going over there...VERY high gross margins for Neudexta. Sales teams have ipads - and 40 of the 75 are in "president's club" - an awards club for top performing salesmen. CEO confirmed the sales estimates of nearly 30mil this year are probably in the right ballpark. CEO has 2 mil. shares plus options so he is determined to raise share price.
PR actually says "on or about february 10th"
Didn't want my post to be misleading. You may possibly be able to buy before the 10th...