I read Fuerstein's piece and wonder why he asked Prof. Davis to act as hatchet man. Biotech investors try to avoid scams and shams yet that is what Prof. Davis has concluded about SPHS without any background or basis for his opinion. Granted the company is small and has limited focus but nothing that would suggest a scam. If he has more he should tell us.

I read Fuerstein's piece and wonder why he asked Prof. Davis to act as hatchet man. He is certainly intelligent and nasty enough to do it on his own. That said the only conclusion you can draw from Pro. Davis' comments is that SPHS is a scam or a sham and I think we deserve some basis for that opinion. I try to avoid those types of companies as does every biotech investor. So far I have seen nothing to put SPHS in that category though it's small size and limited focus does give one pause.

I still like CPST but thought the flat product revenue Q over Q was disappointing. As I mentioned previously at the end of last fiscal year CPST had about 140 M of product backlog. That amounts to about 35 M each Q. but only about 24 M was shipped in each of the first 2 Qs. That means about 10 M of backlog each Q is being deferred or canceled. Jamison explained in an answer to Ajay that CPST has seen a slowdown "in order development in process and closing." I think that is his way of saying orders are being deferred or canceled. So CPST can talk about the great backlog but if it isn't translated into delivered product it doesn't mean much. I have been a CPST shareholder for years and thought these machines would fly out of the factory but sales have been harder to close than I ever would have imagined.

I didn't expect my comments to elicit such a thorough response. Every investor looks at matters from his or her own perspective. For me CPST is becoming a more risky investment as each quarter passes. Not only for the reasons mentioned but because of difficulties raising prices and reducing costs, lack of substantial new orders (still waiting for Origin), 6 months or more delay of 250 (once last half of 2012 was given as a production date), maybe the cancelation of 370 altogether, delays in getting a truck deal(remember a year or 2 ago when a deal was going to happen before the end of the Q?), and the heavy reliance on the oil and gas industry (now 70% of sales)for growth. All of that notwithstanding I am still long CPST, but reduced for what I perceived as the increased risk.

There certainly is some investor uneasiness. This quarter may be telling. We expect quarterly progress and have gotten it to date, albeit slow progress. Each quarter that passes without profitability increases the risk that something may go wrong - warranty problems, Greenevironment, or something else. I have been a long time supporter of CPST and like the technology, but we now have 300 M shares outstanding and CPST is only selling 25 M of product and lossing nearly 8 M each Q. At the end of last fiscal year there was 140 M order backlog but only 24 M of product was produced last Q. Even assuming 2 M was left on the dock we should be hitting 35 M of product each Q to get rid of the backlog. We shall see soon. In addition, the latest financing was at .94 with some warrants now priced at 1.26 that expire on 10/31. Another tranche may be put to this investor within the next 6 mos. at an 8% discount to market price. Lastly, shorts have deceased by about 10 M and this would ordinarily be good but you would expect some increase in pps as that happens. We have had a decline which means a lot of selling. I can't imagine what the pps would be without short covering.

The article states that after 5 years the engine of the microturbine must be replaced. I looked at the CPST product literature and could not find information that gave guidance on the useful life of a MT. Does it vary with size and application? Can anyone shed some light on this? Thanks.

If you add another column for daily price change to your chart to last weeks's short sales as follows:
Mon. -.05
Tues. 0
Wed. +.04
Thu. -.01
Fri. -.02

This week's short sales:
Mon. -.03
Tues. +.08
What I am looking at is the control shorts have over the pps. If a stock is in serious decline shorts will nudge it a bit here and there but when selling stops the shorts have to get busy. Yesterday over 50% of volume were shorts and pps went up .08. Seems to me that the shorts had to struggle to keep the price under control. If this high percentage of daily shorting continues with no decline in pps then the shorts will have lost control of the stock. Shorts cannot maintain over 50% of volume with a persistent increase in price. Even if all of the buying were shorts covering total shorts would still increase. Anyway, just more fooling around with your numbers. Jack

Thank you for your thoughts. I haven't looked at Shortsqueeze.com though I have seen that site referenced frequently. The volume of the short selling itself doesn't tell me much but if you combined volume with change of pps you might have something. That is, if short volume was 60% and it knocked down the pps .10 you could get an idea of the power of the short selling you referenced. Perhaps that is how power is calculated. In any event, if you saw that increased short sells were achieving smaller and smaller reductions in price you might be able to identify a turning point. Might be like a swimmer treading water. More effort to stay still in the water than to swim. Likewise, you might have more short sells at the turning point than during a decline.

I am not sure what to make of your daily short numbers. They don't tell us net short numbers do they? The idea for shorts is to force the price down to generate additional sales and not additional buys so they can cover at lower prices. Because the total shorts now is about an all time high at 42 M it seems to me that shorts would be reluctant to up their numbers. In fact, as the pps is forced down by additional shorting it may be that other shorts are covering. How do we know? It would be informative to locate that point when additional shorting generates increased short covering.

On February 29, 2012 CPST sent out a news release announcing an equity offering "expected to close on or about March 5, 2012." There has been no news release announcing the closing. Is there something occurring that should concern us? If so, what? The shorts have been in control of this stock for months and I wonder what they know that we do not.

Captain: You are correct that the buy price is .98 or .19 from the 1.17 exercise price. I suspect the warrant holders were short the stock at much higher prices. A skeptic would say some shorted yesterday at the day's highs and then had shares given to them at .98 to cover. Jack

It cost CPST about .19 for each share exercised. The number of warrants (1,593,490) times .19 equals approx. $302,765. If the closing price yesterday was $1.14 then the warrant holders got CPST for .95. CPST received additional financing of $1,561,620 which may not have happened if the share price was not at $1.17 on the date of exercise. So it seems to me to be an OK transaction. Just like everyone else I would prefer CPST get additional money through sales and profits. Jack

Daberfeldy over at IV has some different numbers. The $1.17 tranche cost CPST .35; the $1.60 tranche cost .90; and the $1.34 tranche cost .94. There were 13,489,000 warrants exercised and $8,323,000 net cash received. Cash received per share was .62. So what does this measn for the pps? My guess is that most of the exercised warrants already had shares sold short against them. Market makers bullied the pps down today to buy back their short positions. Secondaries are ideal ways to close out short positions and management never seems to care, probably to keep avenues open for future financings. Anyway, after some turmoil it probably is a net positive for CPST so long as it continues to make sales.

No published short position for GGHC that I know about, but we do know that GGHC buys on margin and then balances its long position by selling short. That strategy is set out in its web page. As I recall GGHC's long position has gotten larger as CPST's shorts have grown. Can we assume a large portion of that short position is GGHC? I think so, but have no way of proving it. If GGHC's long position declines by 12% it will be interesting to see if the total CPST shorts also declines. If so, rather than the decline in CGHC long position being a negative it might actually be a positive. Short investors are smart and I would like to see both GGHC's long and short positions unwind.

Recent insider sales...

As I recall GGH has a large short position. It seems likely to me that the 12% reduction in its long position matches a similar
reduction in its short position. I say this because its long and short positions seem to grow at the same pace. We will see when the shorts are next reported.

I assume you are refering to YMI's tesmilifene when the DSMB calculated a hazard ratio at its 3rd interim analysis and concluded that the P III trial should not continue. That was in early 2007 and much has happened since then. Though pheromones may be at work they are now attracting investors to other YMI products for other indications. In fact, those pheromones may be working best on YMI's CEO who just bought 100,000 shares on the open market.

I would not be so sure that some scamming is not occurring. I
have no position at this time but have followed the company for years. Perhaps the recent pumping (
http://www.stockshaven.com/ )is to allow "investors" from the
last cash infusion to get out at a nice profit. The fundamentals of the company remain the same - an interesting drug but one that the FDA has put off again and again. The FDA didn't think there was enough data on "durability of subjective sleep maintenance efficacy in adults with insomnia." Management reanalyzed existing data for a resubmission which the FDA would not consider for another 6 months. Ultimate approval is still a big question mark IMO. These are my concerns so do your own DD.

My reference in my last post was to SOMX's first P III trial. Unfortunately SOMX doesn't have any money and no easy way to get it. Its MC is so low that I would think selling the company is a strong possibility but that would be best for shareholders and not necessarily for management. Since it is clear there are no safety issues and some BS subjective results must be submitted maybe other entity will bite on this one. The poster RKRW followed SOMX a few years ago and might have some insight. One last editorial comment: the FDA never was a partner to SOMX in this approval process. It delayed the process several times, the most recently it continued the PDUFA date for 3 months - for what? To tell SOMX that it needs some subjective results to establish efficacy? Really mean spirited IMO and I will be interested to see what happens to DSCO which is only similar to SOMX in that the FDA doesn't seem to like it.

So it looks like it will be at least another 6 months. What I read from the PR is that there are no longer any safety issues with Silenor. The FDA was concerned about "objective and subjective efficacy" to obtain approval of a cronic insomnia treatment. Does this mean that SOMX's P III for transient insomnia is acceptable? It makes sense since the focus of management is now on an additional analysis of the "durability of subjective sleep maintenance efficacy in adults with primary insomnia." This relates to the first P I which reported objective data for chronic primary insomnia. It was a 35 day trial with adult (not elderly) patients. All endpoints were met with statistical significance except LPS which SOMX has decided not to persue. Now it appears SOMX must go back and mine the test results for subjective data in these adult patients. If there is subjective data for the elderly can that be used for adult patients? The devil is in the details.

Interesting find. I note that these are shares represented by restricted stock units that do not vest until the first commercial sale of Silenor in the United States. Although I am generally against repricing options or last minute grants perhaps the action gave the market some confidence that management believes Silenor will be approved. Something gave the market confidence because the stock is up about 90% as I type this. Let's hope that the gains continue after the FDA meeting on Monday.

As an investor in SOMX or any small biotech all you can do is review the public information, make your best guesses and hope that the FDA gives your company a fair shake. We can only hope that the FDA business plan is not one where it takes a dislike to a proposed drug and lets millions be spent in the approval process before finally rejecting the drug after final submission. Companies like ENCY and DSCO do not inspire confidence. In any event, assuming the FDA did see some issues "relating to the interpretation of the efficacy data" and that the company needs clarification, we must ask did those issues relate to all 4 phase III's or only one. Perhaps there are some assumptions in the efficacy calculations that are being questioned. As lowly shareholders we have no way of knowing. But that said we do know confirmatory safety data was recently submitted and the FDA previously noted there are "no adverse events that would preclude approval." Therefore, I think that approval will come and the question becomes how quickly and how much and what kind of financing is necessary in the meantime. As I mentioned in my previous post I think management has taken the right steps to pay off loans, cancel bonuses, terminate leases and so on to make itself more attractive to a 3rd party or to obtain additional financing. I think there is even an option to go "virtual" until approval. In any event, my money is on eventual approval and it won't be until after the meeting with the FDA that we will be able to judge the cost of meeting the FDA concerns. I think there is a possibility that we might get lucky and see approval in June. That would result in a pps many times what we have today.

The meeting with the FDA is April 6th, not April 7th. Perhaps the issue you raised has to do with SOMX now being on the Reg SHO list for over 13 days. There was obviously a great deal of justified shorting when the FDA found issues in the application for Silenor. Since then the company has raised $1M in the return of its license for Nalmefene. In addition, it has paid off a $15M bank loan and terminated its building lease. It again stated it is looking for additional financing and talking to 3rd parties about partnerships. Therefore, IMO management is taking the right steps to avoid riding the company into bankruptcy. I like the risk and bought some shares at the current price.

Clinical / Regulatory / Litigation Calendar

[Please keep entries up to date! See
updating procedure at the end of this post.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: SOMX. (Just noted the PDUFA date of 12/1/08 now changed by FDA to 2/28/09.)


ACHN – ACH-1095 (a.k.a. GS9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.

ACUS - Imagify (ultrasound imaging agent) to be reviewed by the Cardiovascular and Renal Drugs Advisory Committee (of CDER). Advisory Panel: December 10, 2008; PDUFA date: Feb. 28, 2009

AMLN – LAR NDA submission date unknown—on 11/4/08, FDA said scale-up bioequivalence data inadequate.

ANDS – ANA598 (HCV non-nucleoside polymerase inhibitor) phase-1b monotherapy data from three cohorts 1Q09; start phase-2 mid 2009.
ANDS – ANA773 (oral TLR7 activator) phase-1b HCV monotherapy data from 1st cohort 1Q09, all cohorts 2Q09; start phase-2 mid 2009.

ARYX – ATI-5923 (“enhanced warfarin”) phase-2/3 data mid 2009.

Bayer – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)

BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.

CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.

DNDN – Provenge 9902b study: final analysis (304 deaths) mid 2009.

DYAX – DX-88 for HAE: PDUFA date 3/23/09.

ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.)
ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)

GENZ – Myozyme sBLA for second production site: PDUFA date 2/28/09. (Old PDUFA date of 11/19/08 was scrapped when FDA requested GENZ to submit protocol of a post-marketing study. The sBLA has been converted to an application under Subpart E accelerated approval.)

GILD – GS9525 HCV NS4A inhibitor: see ACHN.
GILD – GS9190 HCV polymerase inhibitor: start phase-2 by end 2008. (QT-prolongation deemed acceptable at 40mg BID dose, as announced on 3Q08 CC.)

GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.

HEPH - Triolex (HE3286) Phase II for type 2 diabetes should complete enrollment end of 2008, interim results Q1 2009. "TRIOLEX appears to act independently of the PPAR-gamma nuclear receptor and thereby may avoid the side effects associated with the current glitazone class of insulin sensitizing agents, such as Avandia(R) and Actos(R), which work through the PPAR-gamma pathway."
Triolex Phase I/II for ulcerative colitis, complete enrollment Q1 2009, Data Q2 2009
Triolex Phase I/II Rheumatoid arthritis, complete enrollment Q1 2009.

HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.

IDIX – See #msg-32683478.

ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.

INSM - ALS update Q4 '08 expanded access program in italy (likely before end of nov)
INSM - MMD IIb interim analysis Q4 08. IIb ends december 2008, final data Q1 09.(optin moment at that time by ipsen/genentech) .
INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data May 2009.
INSM - INS-19 P3 INS submission Q4 '08(neupogen generic)
INSM - INS-19 P3 inititation Q1 '09
INSm - INS-20 P1 started Q4 '08 (neulasta generic)
INSM - INS-20 P1 data Q1 '09

ITMN – ITMN191 & & INFORM-1 all-oral HCV cocktail: see Roche.
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).

MAXY – See Bayer.

MNT – PureTox botulinum toxin: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)

MNTA – FDA decision on Lovenox ANDA: probably 1Q09 or early 2Q09 (response to FDA was submitted on 9/26/08). Amphastar’s 180-day exclusivity expires 4/1/09.
MNTA – M118: report phase-2 data in stable angina: 2Q09; ink partnership deal: mid 2009.
MNTA – Copaxone ANDA: end of 30-month stay Jan 2011.

MRX – FDA action date on Reloxin BLA: 1Q09 (no further detail provided by co).

NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).

NVAX - Pandemic (bird) flu Phase IIa, final safety data complete 2008.
Seasonal Phase IIa top line results for safety and immunogenicity end of 2008. (some observed non-serious side effects mentioned in 11-10 earnings release http://biz.yahoo.com/prnews/081110/nem059.html?.v=67 ).

OXGN 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN 1H 09 OXI4503 preclinical data in liquid tumors
OXGN 1H 09 Initiate OXI4503 Phase 1 (AML and liver tumors)
OXGN 1H 09 Initiate Zybrestat ophtamology study
OXGN 1H 09 Final Phase 2 data in Zybrestat ovarian cancer
OXGN 2H 09 Interim Zybrestat NSCLC Phase 2 data
OXGN 2H 09 OXI4503 Phase 1 data (solid tumors)

PFE – Apixaban program: see BMY

Pharming – Rhucin submission to FDA late 2008; resubmission to EMEA with new data early 2009.

PIP – Phase-1 Protexia results 2Q09.

RDEA – Start phase-2b combination study of RDEA806 in HIV: 1Q09; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 1Q09.

Roche – INFORM-1 all-oral HCV cocktail: 2-week data at EASL 4/08.
Roche – ITMN-191 data from 14-day triple- combination study: late 2008.
Roche – R7128: phase-2a 28-day EoT data mid 2009; start phase-2b 1H09.

RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR for 48-week arms: late 2008/early 2009. (SVR for the 28-week arms and SVR12 for the 48-week arms were reported at AASLD.)

SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS) late 4Q08; Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)

SOMX - PDUFA date of SILENOR for insomnia: 2/28/09.

TARG - PDUFA date for Oritavancin: 12/8/08

UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
UTHR - FREEDOM-M top line results End of March, 2009

VRTX – Telaprevir ph-2b PROVE-3 trial in treatment-experienced HCV: SVR data in all arms 1H09. (SVR12 for Telaprevir arms and EoT data control arm were reported at AASLD.)
VRTX – Telaprevir ph-2 ‘C208’ trial testing BID vs TID dosing: EoT data: 1H09; SVR 2H09. (12-wk data were reported at AASLD).
VRTX – Telaprevir ph-3 ADVANCE trial: dosing of all 1050 patients complete Jan09; SVR data 1H10.
VRTX – VX-500 second-generation PI for HCV: phase-1b data 1Q09.

VRUS – R7128 & INFORM-1 all-oral HCV cocktail: see Roche.
VRUS – PSI-7851 2nd-gen nuke for HCV: file IND 1Q09.

VVUS - Qnexa Top-Line Equate (obesitas) dec '08 (BMI 30-35)
VVUS - Qnexa Top-Line extension diabetes data (DM-230) dec '08
VVUS - Qnexa Pivotal trial data obesity (OB-302) Mid 2009
VVUS - Qnexa Pivotal trial data obesity (OB-3030 Mid 2009
VVUS - File NDA Qnexa obesitas Late 2009


ZGEN – IFN-Lambda ph-1b: EoT data from 3mcg monotherapy cohort and 1.5mcg combination cohort at EASL Apr 2009.
ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10

--
Procedure for Updating Calendar

When adding or modifying entries, please follow these steps:

1. Copy the complete text from the old calendar.

2. Make your additions or modifications, inserting new items in alphabetical order.

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Clinical / Regulatory / Litigation Calendar

[Please keep entries up to date! See updating procedure at the end of this post.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: ARYX ITMN Roche VRUS SOMX.



ACHN – ACH-1095 (a.k.a. GS9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.

ACUS - Imagify (ultrasound imaging agent) to be reviewed by the Cardiovascular and Renal Drugs Advisory Committee (of CDER). Advisory Panel: December 10, 2008; PDUFA date: Feb. 28, 2009

AMLN – LAR NDA submission date unknown—on 11/4/08, FDA said scale-up bioequivalence data inadequate.

ANDS – ANA598 (HCV non-nucleoside polymerase inhibitor) phase-1b monotherapy data from three cohorts 1Q09; start phase-2 mid 2009.
ANDS – ANA773 (oral TLR7 activator) phase-1b HCV monotherapy data from 1st cohort 1Q09, all cohorts 2Q09; start phase-2 mid 2009.

ARYX – ATI-5923 (“enhanced warfarin”) phase-2/3 data mid 2009.

Bayer – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)

BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.

CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.

DNDN – Provenge 9902b study: final analysis (304 deaths) mid 2009.

ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.)
ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)

GENZ – Myozyme sBLA for second production site: PDUFA date 11/19/08.

GILD – GS9525 HCV NS4A inhibitor: see ACHN.
GILD – GS9190 HCV polymerase inhibitor: start phase-2 by end 2008. (QT-prolongation deemed acceptable at 40mg BID dose, as announced on 3Q08 CC.)

GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.

HEPH - Triolex (HE3286) Phase II for type 2 diabetes should complete enrollment end of 2008, interim results Q1 2009. "TRIOLEX appears to act independently of the PPAR-gamma nuclear receptor and thereby may avoid the side effects associated with the current glitazone class of insulin sensitizing agents, such as Avandia(R) and Actos(R), which work through the PPAR-gamma pathway."
Triolex Phase I/II for ulcerative colitis, complete enrollment Q1 2009, Data Q2 2009
Triolex Phase I/II Rheumatoid arthritis, complete enrollment Q1 2009.

HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.

IDIX – See #msg-32683478.

ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.

INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data May 2009.

ITMN – ITMN191 & & INFORM-1 all-oral HCV cocktail: see Roche.
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).

MAXY – See Bayer.

MNT – PureTox botulinum toxin: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)

MNTA – FDA decision on Lovenox ANDA: probably 1Q09 or early 2Q09 (response to FDA was submitted on 9/26/08). Amphastar’s 180-day exclusivity expires 4/1/09.
MNTA – M118: report phase-2 data in stable angina: 2Q09; ink partnership deal: mid 2009.
MNTA – Copaxone ANDA: end of 30-month stay Jan 2011.

NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).

NVAX - Pandemic (bird) flu Phase IIa, final safety data complete 2008.
Seasonal Phase IIa top line results for safety and immunogenicity end of 2008. (some observed non-serious side effects mentioned in 11-10 earnings release http://biz.yahoo.com/prnews/081110/nem059.html?.v=67 ).

OXGN 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN 1H 09 OXI4503 preclinical data in liquid tumors
OXGN 1H 09 Initiate OXI4503 Phase 1 (AML and liver tumors)
OXGN 1H 09 Initiate Zybrestat ophtamology study
OXGN 1H 09 Final Phase 2 data in Zybrestat ovarian cancer
OXGN 2H 09 Interim Zybrestat NSCLC Phase 2 data
OXGN 2H 09 OXI4503 Phase 1 data (solid tumors)

PFE – Apixaban program: see BMY

Pharming – Rhucin submission to FDA late 2008; resubmission to EMEA with new data early 2009.

RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.

Roche – INFORM-1 all-oral HCV cocktail: 2-week data at EASL 4/08.
Roche – ITMN-191 data from 14-day triple- combination study: late 2008.
Roche – R7128: phase-2a 28-day EoT data mid 2009; start phase-2b 1H09.

RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR for 48-week arms: late 2008/early 2009. (SVR for the 28-week arms and SVR12 for the 48-week arms were reported at AASLD.)

SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS) late 4Q08; Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)

SOMX - PDUFA date of SILENOR for insomnia: December 1, 2008.

TARG - PDUFA date for Oritavancin: 12/8/08

UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
UTHR - Unblind Oral Treprostinil (combo trial) App. Mid November, 2008 [per 9/22/08 UBS conference last patient dosed about 8 weeks to gather and report data]. Note the Oral monotherapy trial will probably complete late Q1/early Q2 (est.)

VRTX – Telaprevir ph-2b PROVE-3 trial in treatment-experienced HCV: SVR data in all arms 1H09. (SVR12 for Telaprevir arms and EoT data control arm were reported at AASLD.)
VRTX – Telaprevir ph-2 ‘C208’ trial testing BID vs TID dosing: EoT data: 1H09; SVR 2H09. (12-wk data were reported at AASLD).
VRTX – Telaprevir ph-3 ADVANCE trial: dosing of all 1050 patients complete Jan09; SVR data 1H10.
VRTX – VX-500 second-generation PI for HCV: phase-1b data 1Q09.

VRUS – R7128 & INFORM-1 all-oral HCV cocktail: see Roche.
VRUS – PSI-7851 2nd-gen nuke for HCV: file IND 1Q09.

ZGEN – IFN-Lambda ph-1b: EoT data from 3mcg monotherapy cohort and 1.5mcg combination cohort at EASL Apr 2009.
ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
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Surf:

Any idea what is happening to SOMX. I like the story but it is approaching its yearly low. FDA approval (or otherwise)
is less than 6 months away.

Jack

Anyone on this board familiar with OPXA. It had a big up day yesterday but volume is light and it could go down just as fast. It is in PIIb trial for Tovaxin for the treatment of MS. Science looks interesting and it is a big indication for this small biotech. Jack

Probably related to its recent announcement that the NDA filing for Silenor would occur next month and that partnership talks were continuing. I added a little around 4.00 so am pleased with this move. I hope it holds.

Jack

Everything seems on schedule yet the stock is being hammered. I hope there is nothing that I am missing because at these levels SOMX seems like a good play at this time. If the NDA occurs mid February partnership talks should begin in ernest.

Jack