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The IMP321 immunotherapy pipeline looks interesting, and presents a R/R opportunity that could be quite favorable. After DD and conferring with another biopharma trader, I have decided to take a 25K share buy. GLTA!!
Um, when a biopharma co. halts a clinical trial, and fails to pursue the path to a NDA, successful PDUFA, etc. that drug program is DEAD. Sorry if you're holding a bag of this. There may be value in IMP321, but CVac is dead.
Yeah, I read it and more. CVac is dead....dead. Nobody should put a dime into this company for CVac. The other therapies, maybe. Huge risk with possible reward.
Trying to do DD on PBMD, and not sure if this board will offer much help....BUT hey, surprise me!! Looks like company pulled the rug on CVac in Feb 2015. Then released data on 2nd remission ovarian cancer in May 2015 which caused a massive (irrational) spike. With p = 0.07, however, company has elected to not pursue CVac further. It's dead. Any interest in this company should be based solely on the immunotherapy pipeline.
Understand pharmacology of CVac. Trying to understand clinical trial results as relate to SP. Huge spike in May due to CAN-003 data wrt secondary remission in ovarian cancer. Why tumble in SP? Why CAN-004 trial cancelled? No elaboration at PBMD site on this. Just says following board review, decision to focus on LAG-3 programs. Trying to do DD. Anybody elaborate on this? Ok, was CAN-004 trial closed (not cancelled) and we are now waiting on OS data for that trial? Is that the next catalyst? Did SP fall so far after May data release when realization that T-Cell activation occurred, but no antibody production, allowing humoral immunity to keep cancer in remission?
What's the point of this?! Y'all studying the carboxyl group? LOL!
Yup, got all that. You sound defensive -- no need. I don't buy the "prodrug" argument. If FDA weights pharmacology more than molecular structural differences, then NCE is awarded. If form over function for NCE, then no dice.
Best regards.
Yup, I get that.
It seems, at least in part, a matter of whether molecular structure is considered moreso than drug's pharmacology.
Thanks.....This clarifies some of the confusion. LOL!
Hey, appreciate the thoughts. I consider an ethyl ester to be an ester, as that is the functional group. Likewise, the alcohol part of an ester could be methyl, propyl, butyl, etc.
Now, as far as this "prodrug" observation -- isn't that what the filing of a NDA is all about? They got that with the PDUFA. But that's not equivalent to NCE.
Biochemist, but not in pharmaceuticals, and been trading biopharma for just a year. Could be missing something.....Dunno.
Because they haven't said yes! Geez, you want me to re-post my answers to that question like I did on ST? Again, please, some of you respond to the findings/conclusions of the Hogan/Lovells paper cited below:
http://ehoganlovells.com/rv/ff000ba2265e016b88cc630cea42b3d7995a45df
Thanks in advance.
Those thinking that NCE is guaranteed are asked to comment on the following:
http://ehoganlovells.com/rv/ff000ba2265e016b88cc630cea42b3d7995a45df
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/02/function-over-form-or-form-over-function-two-petitions-challenge-fdas-nce-exclusivity-approach-for-c.html
Long AMRN. Just believe the whole "prodrug" thing is a red herring.
Best regards.
Initiated a new position with a 5.03 buy today. Hopefully we have a reversal here.
Sooooo, is this company being run by a bunch of high school kids trying to play corporate officers? Finally get the damn drug approved, then take 2 years gettin' it launched. Maybe I'm being optimistic.
FYI:
http://www.hlregulation.com/2012/10/01/fda-denies-5-year-exclusivity-to-stable-esters-and-confirms-structure-based-approach-to-exclusivity/
Read this last fall and predicted NCE denial. Any thoughts?
Gotta tell ya, the FDA does not act on compassion or what makes for "good business." NCE could happen, but looks like a long shot to me.
If can't hold 1.75, support at 1.50. Looking to enter soon, for run to ~4, 2nd quarter 2013.
Howdy! Established a new position at 0.32 today. Was just lookin' for a swing, but after some research on PEIX, am now thinking long.
PM up a tick.....Lookin' to see if this breaks, and which way of course -- up, hopefully. In from 0.41 and passed on selling in low 0.60s yesterday. LOL!
Wanna be in when NDA filing announced, ya know? Soon?
Stock price reversed due to info on "mixed shelf" offering leaking. Otherwise it was moving-up strong -- fought off sub 4.40 day before, burned some shorts, and was 4.80 PM. What a scam. LOL!
Looking for re-entry Thursday/Friday. If Class I review, then September PDUFA I imagine. Stock should climb nicely given position prior to May PDUFA.
Cheers!
Stopped-out early today........4.37 from 2.68. Another offering/dilution it seems. Re-entry once this plays out.
Nice map, bad chart, no oil......Out GLTA
Seriously? You love dry wells? You wouldn't have wanted Gretel to be a gusher? I have just 4K shares @ 1.72, but I'd rather make $$ than lose $$. Not selling, not happy.
Well, second oiler of mine to hit dry wells this year......Maybe I'll stick to pharma. LOL!
Howdy! Been out since that last run to about 3.15. Just re-entered at 2.31......Couldn't resist the price. Hopefully goes no lower.
As stated previously, I'm a short/medium term swing trader new to AEZS. If a NDA for AEZS-130 is submitted, what keeps this from doubling?
Any insight into the Phase III data release this week? That will tell the tale.
Also, cross fingers that the Greek vote comes out favorably. Bad vote with bad data and AEZS is probably screwed.
Howdy! Entered a new position at 0.41 on Thursday. Expecting great things to follow.
Howdy! Entered a new position at 3.98 this morning in anticipation of run-up to July PDUFA. Go HZNP!
Thanks for the good read. A young doc and I took ole Adam to task for an article that sabotaged Galena's NeuVax. Stripped his erroneous article to the bone point-by-point and he never responded to us.
Yup, new to the game, but a researcher, and puttin' in the time. Learning TA right now.
I'm inclined to agree with you about ARNA. The other drugs I've researched (including VRTX's Kalydeco but excepting NeuVax), have a limited patient base.
Definite stress sitting through a PDUFA with significant skin in the game, but I've done it 3 times now and will probably do it on 6/27.
So, it'll be interesting to see how this all transpires with ARNA. Which of the following?:
1. SP climbs slow & steady to PDUFA, approval, big pop, some
retrace, continued climb.
2. SP bases, then bounces between 5.50 and 6.00 over the next
month, leading-up to PFUFA.
3. Same as #2, accept SP pummeled just prior to PDUFA like
happened with PLX (and ALXA somewhat). Remember, PLX was
approved.
4. Others?
Exactly, that's the question.....Is it possible to figure that one out. While I look forward to responses from others, let me relate recent biopharma experiences. Now, if the reader is one of those who has drank the Kool-Aid, and wants to hear only pie-in-the-sky proclamations, do us both a favor and stop reading now.
I started stocks just a few months ago. My academic background is biochemistry, but I don't work in biopharma. My introduction to pharma was with Discovery Labs (DSCO) and the PDUFA for Surfaxin. After a weekend of digging-up and reading tech papers, FDA Tracker reports, "pump" articles in Seeking Alpha, etc. I called for APPROVAL. This was contrary to FDA Tracker and Adam Feuerstein's panel of experts voted CRL also (albeit by just one vote). Surfaxin was approved. The stock price had risen steadily for the previous few months, and was at about 3.60 when the halt was called. I had 3000 shares at 3.57. Announcement came just after market close and SP immediately shot over 6 bucks. I could have then doubled my money, but held. It was my first PDUFA experience and I was on cloud nine. The next morning management held a conference call, at the end of which a major stock dilution was revealed. SP plummeted. I was lecturing. I sold for just a $400 gain....Coulda had 9K. DSCO is now trading at 2.40....Over a buck below SP at time of halt. If I had held long I'd now be down about $3200.....For making the right call.
After doing not much DD on KERX, I called CRL for KRX-0401 (Perifosine). PDUFA was CRL.
Alexza's quest for approval of Adasuve (Staccato Loxapine) is the most interesting to me. Feuerstein said too close to call , but his "guess" would be CRL. For me this was tougher than DSCO or KERX, but I called for APPROVAL. ALXA got a CRL. Here's the key thing: CRL was due to a recent FDA onsite inspection of Alexza's manufacturing facility, and not part of the public record. Alexza previously had to lay-off most of it's staff due to tight finances. I conjecture the inspectors found concerns about proper hygiene and sterile environment. So, I was correct about the drug itself, but suffered a CRL all the same. I still made $$. Held 12,900 shares at 0.54. SP was consistently around 0.60 until 2 days prior to PDUFA. Day before PDUFA SP went to 0.78, then started down. I sold 2/3 of my position at 0.74 and held the rest. During the afternoon, SP was knocked down to 0.58. After CRL SP went to 0.36 in AH, but climbed to 0.51 the day after, where I sold my remaining 1/3. Now at about 0.40.
If you're still with me, check-out the 3 month chart for PLX and match it with the PDUFA date of May 1st. Yeah, May 1st, and the drug was APPROVED!! Amazing. I wasn't in on this one.
Respectfully submitted,
SciGuy
Thanks for reply. Like I said initially....Looking to establish a position in ARNA. Haven't previously invested in the company and just started DD Friday night. Sooo, I haven't been in from 1.70 (or whatever), won't likely have a nice cushion going into the PDUFA, and need to get it right. Since this is biopharma, getting it right is sometimes not enough. :)
My post was mostly me thinking out loud, and hoping for a response from savvy investors. Glad for your reinforcing of my suppositions.
Thanks for the intelligent, productive reply. I do the best DD I can before putting my $$ on the line. Okay, back to the research. :)
SciGuy
sts66, et.al. Hey! Looking to establish a new position in ARNA, but need help with a few issues:
Arena took a "bird-in-hand" approach to PO. Why not raise capital after PDUFA if sure of approval? Could've gotten much more then. Hmmm....Makes me a little nervous about entry. Arena had plenty of $$ to get to PDUFA without PO.
Believe also there is option to release another 1.60 M shares...Not that much compared to 11 M already, but still something to consider. Any thoughts about this?
One more item....Offering at 5.50 to institutional investors not terribly impressive IMO. Why not go for bigger money?
Could be hedging against a possible 3 month extension, which might be a reasonable and responsible action by Arena.
Thanks for any insight!
SciGuy
Hey! News on 5/17 about Spirit 3 penetrating NaCl layer that was being an issue. Well now can be drilled to full depth as indicated by seismic analysis.
Any thoughts or more info on this? SP looks really low, and I don't see much downside risk here.
Well I wouldn't expect the "problem" to emanate from back in 2011. Probably a relatively recent inspection of the facility. If so, this is particularly unfortunate.
CC is key tomorrow.
Hey! I'm a biochemist and biopharma trader. Did DD on ALXA and called for approval. My understanding is that this is a "soft" CRL. Some issue at the facility during an FDA inspection. No new trials/studies required. Basically, clean-up the problem and get approval. Anybody know different?
I used to think all I had to do was analyze scientific publications....Now I guess visiting the facility is required. LOL
Do you suppose problem might be related to staff reductions? Not enough people to keep the place up to snuff?
Anyway, keep-up hope....this might not be so bad afterall.
SciGuy
Hot chart..........just need some buyers.
Possible "morningstar" pattern.....On watch for tomorrow. Needs volume.