Replies to post #18894 on Biotech Values

[terry hallinan]

DSCO - The pump that failed.

You can't get a surer thing than Discovery Laboratories despite the horrible inability to find a decent name. Or can you?

If DSCO finally converts its approvable letter into approval next year, its targeted infant respiratory distress syndrome (IRDS) could be just the beginning of treatments for huge markets but additional development will be required.

Perchance some inconvenience in preparing the synthetic surfactant besides the marketing muscle of behemoths with their minced animal lungs may not make the route to domestic market success for a home-grown sales force quite as easy it appears on the surface.

"Why didn't JNJ develop their IP themselves instead of licensing it to DSCO?" my wife asked at the annual meeting years ago. She is always doing that to me. That's the way wives are as any married man can tell you.

I don't really know why. I can speculate, e.g., why not let some former executives and any suckers they can get to take the risk while JNJ collects the gravy and maybe later the company. But we don't allow such speculation on this board do we? :-)

"Great management," I told my wife. "They got great stuff from from the dumbo and will have huge markets to themselves soon."

"Do I get a new kitchen soon?" she responded.

"Soon" has turned into years.

The testing went swell. Really swell. Not so the NDA. I suppose most everyone knows about the "manufacturing" problem that included the FDA worrying about the size of the label on the bottle.

I got to tell you visions of black helicopters have occasionally danced before me. Perhaps just my overactive imagination.

Undoubtedly management wasn't too bright when they announced they had submitted volumes for a complete response to the FDA's approvable letter. I got a sudden attack of respiratory distress syndrome and adult respiratory distress syndrome (ARDS) won't be available for awhile, if ever. This ex-bureaucrat remembered not being fond of having volumes delivered with a forklift. "Fatheaded" instead of "not too bright" is a more apt description of that management tactic I think. I began to spy a problem beyond those imagined black helicopters.

Management was very bright in other ways. Those hidden collars on their stock that allowed a kind of sale on excellent pivotal trial results without notifying shareholders were a lot more intelligent than this idiot's hold.

The future is still on the way.

I think.

Management has some smarts that is not always appreciated by everyone.

Especially my wife.

Best, Terry

[DewDiligence]

Clinical / regulatory / litigation calendar:

[Please see updating procedure at the end of this post.]


Edits: Delete PTIE entry for Oxytrex (results already out).


ABGX - PACCE trial (chemo+Avastin+/-Pani) in 1st-line CRC: first interim RR 4Q05; Pani “408” trial in 3rd-line CRC (the trial that just caused all the commotion) final survival: 2Q06.

AGEN - Ph III in RCC 1H06.

AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.

ALKS – 12/30/05 PDUFA date for Vivitrex NDA.

AMGN – See ABGX

AORMF -pivotal AMD3100 results 2nd half 06.

AVN – FDA acceptance for filing of NDA for PBA: delayed (was 10/10/05).

AXCA -pivotal Itax results 1st half 06.

BIIB – Tysabri (resubmission) PDUFA date 3/25/06

BMY – 12/31/05 revised action date for Orencia (CTLA-4).

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.

CONR – CE Mark (EU approval) of CoStar stent: late 2005/early 2006. Final pleadings in U.K. patent litigation: mid-Dec 2005.

COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: PET scan results - IIa Alzheimer's CX-717 Ampakine trial.
COR - Early 2006: Results of IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA).

CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD

CRME - Phase III RSD1235 ACT 2 CABG data in Q4/05 or Q1/06

CYAHF -20 patient IDE results 4th qtr, then begin the pivotal phase 1st half 06 as well as commercial launch in Europe later this year.

CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 study (either 3-mo or 6-mo of follow-up) 3Q06 (maybe —Dew).

DNA- Rituxan in RA PDUFA 2/28/06
DNA- Rituxan in FL Agg NHL PDUFA 2/22/06
DNA- Lucentis BLA submission 4Q 05
DNA- Avastin 2nd line mCRC sBLA filing 4Q 05
DNA- Avastin 1st line mNSCLC sBLA filing 1Q 06
DNA- Avastin 1st line MBC sBLA filing 1Q 06
DNA- Herceptin adjuvant breast cancer sBLA filing 1Q 06

DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC

DSCO - 2ndQ 06 - Approval for IRDS and market rollout

ELN – See BIIB

FRX - Milnacipran in fibromyalgia: see CYPB.

GENR – Interim data in phase-2 “209” study: early 2006.

GPCB – Satraplatin SPARC trial: interim PFS 1Q06, final PFS 2Q04, final survival 2007.

GTCB – EMEA opinion on ATryn: Feb. 2006; Merrimack phase-2b MM-093 in RA: mid 2006.

IDBE -begin pivotal Fluinsure trials this winter.

IMCL – Erbitux PFS in (Merck KGaA) CRSYTAL trial in first-line CRC: 2H06; Erbitux H&N PDUFA date: end of Feb 06 (sBLA submitted 8/30/05).

INSM – Approvable letter received—orphan status pending.

LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.

Merrimack: see GTCB

MYOG - Top-line data from Ambrisentan phase-3 trials in PAH: ARIES-2 in 4Q05, ARIES-1 in 2Q06.

NKTR – Exubera: endorsed by advisory panel 9/8/05 by 7-2 vote; FDA action by late 1/06.

NVS – LAF237 pivotal data in diabetes: early 2006.

PDLI - Q2 06 volociximab ph II for solid tumors

PTIE - PTI-901 Irritable Bowel Syndrome - P.III top-line results in women: 4Q05

PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction

RHEO – Pivotal trial in dry AMD: data being cleaned – expected report 1Q06.

SCLN: Top line results for first HCV pivotal trial by Mid-December 2005
Top line results for second HCV pivotal trial due 1stH06

SPPI – See GPCB.

SRDX - Phase-1 DME data for I-vation w Triamcinilone: mid 2006; Novocell start of phase-1/2 trial in type-1 diabetes: imminent.

TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06

Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 1Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 1Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 1H06.

TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.

VSGN - Celacade phase-3 in chronic HF (ACCLAIM): triggering events reached 11/14/05; data now in cleanup and analysis.

YMI - early 2006?--672 patients enrolled, 28 to go.YM anticipated that the trial might be completed as early as mid-2006, but seems to be potentially ahead of schedule.
YMI - report pivotal Tesmilifine breast cancer results possibly 2nd qtr 06.
YMI – AeroLEF phase-2b data report: 2Q06.

--
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