Tag Archives: stocks

MannKind Corporation: MNKD

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting is scheduled for Apr 1, 2014 (Yes: April Fools Day).
Twitter Conversation
Meeting Materials
Entire Webcast (third-party provider… costs money)

RECOMMENDED APPROVAL

Note

  • I wish this didn’t have such a “salesman” feel… I hate the “pitchiness” of PR appearances
  • Tight timeline for approval… FDA vote was scheduled for about 2 weeks after AdComm
  • While the CTO has sold quite a few shares recently, the CFO, COO and VPHR have bought (fairly small positions) in the past 4 months
Date Open High Low Close Change from Prior
3/27/2014 5.40 5.44 4.87 5.20 -0.18 (-3.346%)
3/28/2014
Materials
5.64 5.75 4.75 4.83 -0.37 (-7.115%)
3/31/2014 4.44 4.60 3.80 4.02 -0.81 (-16.77%)
4/1/2014 Halted for AdComm!
After-Hours trading reached 9.65
4/2/2014 7.75 8.08 6.83 6.99 2.97 (73.88%)
4/3/2014 7.19 7.21 6.66 6.93 -0.06 (-0.858%)
4/4/2014 7.00 7.01 6.70 6.87 -0.06 (-0.866%)
4/7/2014 6.12 6.44 5.97 6.32 -0.55 (-8.006%)
4/8/2014 6.50 6.58 6.30 6.54 0.22 (3.481%)
5-day 7.75 8.08 5.97 6.54 2.52 (62.687%)
  • There was a 7.115% drop on the Close of the Materials Release date from the prior Close… materials were released during the trading day.
  • There was a brutal 16.77% drop on the Close of the day before AdComm.
  • After-hours trading on the date of the Approval vote climaxed at 9.65, for a 140% bump on the Close from the day before AdComm.
  • The first Open after the Approval Recommendation was up 94.03%… within two minutes it maxed out at 8.08, or 101.0% over the previous Close.
  • The first trading day post-vote High was 4.258% higher than the Open, and occurred within the first two minutes of trading.
  • The first trading day post-vote Low was 11.871% lower than the Open.
  • The first trading day post-vote Close was 9.806% lower than the Open.
  • The five-day High was 4.258% higher than the five-day Open, and occurred on the first day.
  • The five-day Low was 22.968% lower than the five-day Open, and occurred on the forth day.
  • The actual HIGH was in After-Hours of the afternoon of the vote, at over 9.65, or 140% higher than the previous Close… After-hours is a pretty terrific exit point.

Durata Therapeutics International: DRTX

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting on Mar 31, 2014.
Twitter Conversation
Meeting Materials
Full Webcast Note: At the access page, please sign in as a guest. No password is required

RECOMMENDED APPROVAL

Notes

  • Durata is meeting regarding dalbavancin hydrochloride for intravenous injection with the proposed indication:
    treatment of acute bacterial skin and skin structure infections
  • Data look good
  • Antibiotics that are safe and effective have an easy go, so less risk (read: reward) than many other types of bio
  • Trading in a comfortable range for me $12-16
  • The CEO and one Independent Director has purchased shares in the past year (most recent insider activity… combined about 4000 shares)
  • Released materials indicate “both trials met their primary objectives[…]also satisfied a key secondary endpoint”
  • Released materials indicate not all endpoints met, and potential Safety issues affecting Liver
Date Open High Low Close Change from Prior
3/26/2014 14.45 14.67 14.05 14.21 -0.12 (-0.837%)
3/27/2014
Materials
14.35 14.97 13.95 14.26 0.05 (0.352%)
3/28/2014 14.40 14.83 13.39 13.50 -0.76 (-5.33%)
3/31/2014
Half Day for AdComm
13.75 13.99 13.22 13.47 -0.03 (-0.222%)
4/1/2014 14.63 14.68 13.80 14.23 0.76 (5.642%)
4/2/2014 14.30 14.39 13.85 14.04 -0.19 (-1.335%)
4/3/2014 14.10 14.16 13.40 13.71 -0.33 (-2.35%)
4/4/2014 13.80 13.90 12.76 12.89 -0.82 (-5.981%)
4/7/2014 12.89 12.94 12.19 12.38 -0.51 (-3.957%)
5-day 14.63 14.68 12.19 12.38 -1.12 (-8.296%)
  • There was a 5.33% drop on the Close of the Materials Release date from the prior Close… I believe materials were released during the trading day… not certain.
  • After-hours trading peaked at 15.50, for a 15.07% bump from the Close (trading halted around noon).
  • The first Open after the Approval Recommendation was up 8.612%… within four minutes it maxed out at 14.68, or 8.09% over the previous Close.
  • The first trading day post-vote High was 0.342% higher than the Open, and occurred within the first four minutes of trading.
  • The first trading day post-vote Low was 5.673% lower than the Open.
  • The first trading day post-vote Close was 2.734% lower than the Open.
  • The five-day High was 0.342% higher than the five-day Open, and occurred on the first day.
  • The five-day Low was 16.678% lower than the five-day Open, and occurred on the fifth day.

Novartis AG: NVS

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting is RESCHEDULED for Mar 27, 2014.
Twitter Conversation
Meeting Materials
Full Webcast Note: At the access page, please sign in as a guest. No password is required

RECOMMENDED REJECTION

Notes

  • Novartis already trading higher than I like, > $80
  • Novartis and Roche face fines in Italy for alleged collusion
  • Phase II trial data as presented looked good… a good solid cancer drug could be a giant win
  • Japan not crazy about allegedly exaggerating drug claims
  • OUCH! From FDA Briefing Info doc: We recommend that serelaxin not be approved at this time because there is insufficient
    evidence to support the proposed indication: to “improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure”.
  • I’d say I’m pretty-well out on this one, folks
  • Panel voted 0-11… Recommend Rejection
Date Open High Low Close Change from Prior
3/24/2014 81.77 81.90 80.77 81.30 -0.43 (0.526%)
3/25/2014
Materials
81.67 82.11 81.21 81.87 0.57 (0.701%)
3/26/2014 81.85 82.17 81.11 81.11 -0.76 (-0.928%)
3/27/2014
AdComm
81.39 81.66 81.07 81.37 0.26 (0.321%)
3/28/2014 82.00 82.22 81.42 81.59 0.22 (0.27%)
3/31/2014 84.74 85.23 84.54 85.02 3.43 (4.204%)
4/1/2014 84.54 84.86 83.99 84.51 -0.51 (-0.6%)
4/2/2014 84.13 84.69 84.07 84.57 0.06 (0.07%)
4/3/2014 83.90 83.91 83.13 83.41 -1.16 (-1.372%)
5-day 82.00 85.23 81.42 83.41 2.3 (2.836%)
  • Inexplicably, the markets did not appear to notice that the Materials were published today, and the FDA docs recommend to NOT approve. My world is shaken… but not stirred.
  • Inexplicably, the markets did not appear to notice when AdComm voted to not recommend Approval today, though they only had a few minutes until close… we’ll see what tomorrow brings.
  • Day after… still nuthin’.
  • Nothing to see here.
  • I’m not going to dignify this with a summary.

EXACT Sciences Corporation: EXAS

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting is scheduled for Mar 27, 2014.
Twitter Conversation
Meeting Materials
Entire Webcast (third-party provider… costs money)

RECOMMENDED APPROVAL

Notes

  • Trading in a comfortable range, $13… I like this closer to $12
  • Fecal Colo-rectal cancer screen called Cologuard®
  • Need to see safety data and efficacy as compared to exiting tests
  • Put:Call ratio is a little high
  • Connections to the second Bush administration could either hurt or help
  • Here’s a dated, but relevant overview of the Deep-C trial results, describing satisfied end-points.
  • Gosh I wish this were a blood test instead of a fecal test… we get blood tests all the time… how often do you like to poop in a box and send it to someone (for medical reasons, of course)?
  • The CEO, CSO and COO most recently sold shares… a few thousand
  • Meeting Materials appear to be favorable to Approval recommendation
  • AdComm voted 10-0 to Recommend Approval
  • After-hours trading generated a resounding “thud”
Date Open High Low Close Change from Prior
3/24/2014
Materials
14.20 14.43 13.61 14.22 0.66 (4.867%)
3/25/2014 14.35 14.77 13.80 14.25 0.03 (0.211%)
3/26/2014 14.50 14.50 13.61 13.75 -0.5 (-3.509%)
3/27/2014 Trading Halted for AdComm
3/28/2014 14.49 14.60 12.52 12.86 -0.89 (-6.473%)
3/31/2014 13.40 14.39 13.26 14.17 1.31 (10.187%)
4/1/2014 14.47 14.49 13.99 14.16 -0.01 (-0.07%)
4/2/2014 14.12 14.33 13.88 14.25 0.09 (0.636%)
4/3/2014 13.60 13.74 12.89 12.92 -1.33 (-9.333%)
5-day 14.49 14.60 12.52 12.92 -0.83 (-6.036%)
  • There was a 4.867% bump on the Close of the Materials Release date from the prior Close… materials were released during the trading day.
  • Best results would have been to have bought on the 21st, four trading days before the AdComm, on news that the Chairman resigned for “personal reasons”. Naturally, this is not where I bought.
  • There was a 6.473% drop on the trading day after the unanimous AdComm Approval vote from the prior Close.
  • What… the… hell?!? “Priced in” is one thing… dropping nearly 6.5% is completely another. This is madness.
  • The first Open after the Approval Recommendation was up 5.382%… within four minutes it maxed out at 14.60, or 6.182% above the previous close.
  • The first trading day post-vote High was 0.759% higher than the Open, and occurred within 4 minutes of trading.
  • The first trading day post-vote Low was 13.596% lower than the Open.
  • The first trading day post-vote Close was 11.249% lower than the Open.
  • The five-day High was 0.759% higher than the five-day Open, and occurred on the first day.
  • The five-day Low was 13.596% lower than the five-day Open, and occurred on the fifth day (second day experienced significant low as well).

EPIGENOMICS AG: EPGNY

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting is scheduled for Mar 26, 2014.
Twitter Conversation
Meeting Materials

RECOMMENDED APPROVAL

Entire Webcast (third-party provider… costs money)

Notes

  • Trading above my comfort level: $45 (at posting)
  • Trading OTCMKTS on microscopic volume… it’s like it’s traded between cousins who rarely speak
  • Quoth FDA Executive Summary document, page 20, section 5.6: “The pivotal clinical study does not meet all of the pre-specified primary performance objectives”
  • I think I’m going to stay away from this
  • … 5-4 say they Recommend Approval, forever changing my world view
Date Open High Low Close Change from Prior
3/21/2014 57.12 57.26 57.12 57.26 0.53 (0.934%)
3/24/2014
Materials
54.70 55.30 54.57 55.30 -1.96 (-3.923%)
3/25/2014 51.88 51.88 49.27 49.27 -6.03 (-10.904%)
3/26/2014
AdComm
49.35 49.35 41.29 41.75 -7.52 (-15.263%)
3/27/2014 42.34 42.34 39.50 40.01 -1.74 (-4.168%) ?!?
3/28/2014 36.36 36.36 36.36 36.36 -3.65 (-9.123%)
3/31/2014 37.76 38.00 37.74 38.00 1.64 (4.51%)
4/1/2014 39.10 39.10 39.10 39.10 1.10 (2.895%)
4/2/2014 40.86 40.86 40.86 40.86 1.76 (4.501%)
5-day 42.34 42.34 36.36 40.86 -8.41 (-17.069%)
  • There was a -3.923% drop on the Close of the Materials Release date from the prior Close… materials were released during the trading day.
  • There was a -10.904% drop on the trading after the Materials Release date from the prior Close.
  • Trading was not halted during AdComm.
  • There was a -15.263% drop throughout the AdComm trading day, prior to any vote, and with limited access to Webcast.
  • There was a -9.123% drop in Close from the first trading day after the successful AdComm vote.
  • It’s difficult to imagine how the Markets would have reacted to a failed AdComm outcome.
  • The five-day High was the High of the first trading day.
  • The five-day High was the five-day Open.
  • The five-day Low was the Low of the second trading day.
  • The five-day Low was 14.124% lower than the five-day Open.

STAAR Surgical Company: STAA

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting was RESCHEDULED for Mar 14, 2014 from Feb 14, 2014 due to weather.
Twitter Conversation
Meeting Materials

RECOMMENDED APPROVAL

Entire Webcast (third-party provider… costs money)

Note

  • I watched the surgery performed on YouTube… I HATE seeing anything touching an eye… this SUCKED.
  • I’m no longer long STAA
Date Open High Low Close Change from Prior
2/12/2014
Materials 2/12
15.75 16.01 14.67 14.70 -0.99 (-6.31%)
AdComm Postponed One Month Due to Weather
3/13/2014 14.73 15.15 14.62 15.09 0.46 (3.144%)
3/14/2014 15.20 15.636 15.20 15.37 0.28 (1.855%)
The Webcast for the AdComm was not publicized.
To my great surprise, there was no firestorm to buy at ridiculous prices in the After-hours market.
3/17/2014 17.99 19.50 17.44 17.70 2.330 (15.159%)
3/18/2014 17.36 17.50 16.44 17.12 -0.58 (-3.277%)
3/19/2014 17.14 17.37 16.67 17.27 0.15 (0.876%)
3/20/2014 17.27 17.35 17.0 17.06 -0.21 (-1.216%)
3/21/2014 17.06 17.06 16.33 16.61 -0.45 (2.638%)
5-day 17.99 19.50 16.33 16.61 1.24 (8.068%)
  • There was a 6.31% drop on the Close of the Materials Release date from the prior Close… materials appear to have been released during the trading day, but not certain of this.
  • Best results would have been to have bought on the 12th, two trading days before the AdComm
  • The first Open after the Approval Recommendation was up 17.046%… within ten minutes it maxed out at 19.50, or 26.87%.
  • The first trading day post-vote High was 8.394% higher than the Open, and occurred 10 minutes into trading.
  • The first trading day post-vote Low was 3.057% lower than the Open.
  • The first trading day post-vote Close was 1.612% lower than the Open.
  • The five-day High was 8.394% higher than the five-day Open, and occurred on the first day.
  • The five-day Low was 9.227% lower than the five-day Open, and occurred on the fifth day (second day experienced significant low as well).

This encourages selling promptly after Open: the low of the first candle after the first red candle, at 8:44am EDT on the day was 18.80. After 8:47am EDT it did not approach 18.80 again.

This disputes the argument that you can short from the Open to cover at 20% of Open: the Low for the day was only 3.057% lower than the Open… in fact the Low was only 10.564% lower than the High.

These points could also suggest NOTHING, you greedy pig!

The Medicines Company: MDCO

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting on Feb 12, 2014
Twitter Conversation
Meeting Materials

RECOMMENDED REJECTION

Webcast to Morning Break
Webcast from Morning Break to Lunch Break
Webcast from Lunch Break to Afternoon Break
Webcast from Afternoon Break to End of Meeting

The recommendation led to a drop of 4.15 (12.5%) from the close at 33.1 on 2/12 to open at 28.95 on 2/13, and of 3.82 (11.5%) to the close at 29.28 om 2/13.

Date Open High Low Close Change from Prior
2/10/2014
Materials 2/9
31.51 32.86 30.50 32.42 -1.80 (-5.26%)
2/11/2014 32.41 34.21 31.82 33.10 0.68 (2.097%)
2/12/2014 Trading Halted for AdCom
2/13/2014 28.95 29.569 28 29.28 -3.82 (-11.5%)
2/14/2014 29.1 30.045 29 29.52 0.24 (0.819%)
2/18/2014 29.655 30.09 29.55 30 0.48 (1.626%)
2/19/2014 29.76 30.872 29 29.84 -0.16 (-0.533%)
2/20/2014 29.67 30.82 29.41 30.64 0.80 (2.681%)
5-day 28.95 30.872 28 30.64 -2.46 (-7.432%)
  • There was a 5.26% drop from the Close of the Materials Release date to the Close after we had access to the info.
  • Best results (in the event of an approval) would have been to have bought on the 10th, two trading days before the AdComm
  • The first trading day post-vote High was 2.1% higher than the Open.
  • The first trading day post-vote Low was 3.281% lower than the Open.
  • The first trading day post-vote Close was 1.14% higher than the Open.
  • The fifth trading day post-vote Close was 5.838% higher than the first trading day Open.
  • The five-day High was the fourth trading day High.
  • The five-day High was 6.639% higher than the five-day Open.
  • The five-day Low was the first trading day Low. In other words: bad news is very fast to be reflected in the price.
  • The five-day Low was 3.282% lower than the five-day Open.

This could suggest covering shorts at 2% below first-day Open and entering long to exit at 5% of the cover price (or could suggest NOTHING, you greedy pig!). With my lot sizes, 2% isn’t worth it, and getting that complicated for an extra 2% would be silly.

Chelsea Therapeutics International Ltd.: CHTP

I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.

Yahoo Finance Quote
FDAAC Meeting on Jan 14, 2014
Twitter Conversation
Meeting Materials

RECOMMENDED APPROVAL

Webcast from Start of Meeting to Morning Break
Webcast from Morning Break to Lunch Break
Webcast from Lunch Break to Afternoon Break
Webcast from Afternoon Break to End of Meeting

The recommendation led to an increase of 3.46 (150.434%) from the close at 2.3 on 1/13 to open at 5.76 on 1/15, and of 2.11 (91.739%) to the close at 4.41 om 1.15.

Date Open High Low Close Change from Prior
1/10/2014
Materials 1/9
2.50 2.72 2.26 2.50 -1.03 (-29.178%)
1/13/2014 2.61 2.62 2.27 2.3 -0.20 (-8%)
1/14/2014 Trading Halted for AdComm
1/15/2014 5.76 5.78 4.28 4.41 2.11 (91.739%)
1/16/2014 4.40 4.80 4.16 4.70 0.29 (6.576%)
1/17/2014 4.75 4.85 4.62 4.76 0.06 (1.277%)
1/21/2014 4.85 5.02 4.64 4.79 0.03 (0.63%)
1/22/2014 4.81 4.85 4.55 4.645 -0.145 (-3.027%)
5-day 5.76 5.78 4.16 4.645 2.345 (101.96%)
  • There was a 29.178% drop from the Close of the Materials Release date to the Close after we had access to the info.
  • Best results would have been to have bought on the 10th, two trading days before the AdComm
  • The first trading day post-vote High was 0.3% higher than the Open.
  • The first trading day post-vote Low was 25.7% lower than the Open.
  • The first trading day post-vote Close was 24% lower than the Open.
  • The five-day High was the High of the first trading day.
  • The five-day High was 0.347% higher than the five-day Open.
  • The five-day Low was the Low of the second trading day.
  • The five-day Low was 12.539% lower than the five-day Open.
  • The actual HIGH was in After-Hours of the afternoon of the vote, at over 6.30… After-hours is a pretty terrific exit point.

This suggests selling at Open and shorting from the Open to cover at 20% of Open (or could suggest NOTHING, you greedy pig!). Still, shorting at all is just scary for me at the moment. In the future I’ll be happy to exit in after-hours, but might go a little short for the experience at that time… certainly not the same position size.

UPDATE! FDA Final Approval was announced on 2/19/2014, about a month after the AdComm recommendation. CHTP went from a 2/18 Close of 4.95 to 2/19 Open of 6.65. An increase of $1.70 (34.34%). It then Closed on 2/19 at 6.16, down 0.49 (7.368%).