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OCRX questions
Oral
I presume re-do P1 is relatively low risk since we had this last year.
Hopefully "new and improved formula" I am wandering about likely design of P2 and expected time to reach POC status?
IV
P2 has been taking almost 4 years roughly and quarterly expense has been about $7 to 8 million. If I presume current P2 is statistically significant, how many years do you think it will take to reach the market?
Do you expect two separate P3 will be necessary for registration? This P2 alone is taking longer than conventional CVOT study. Adding only 7 to 10 patient a month!
ATM
ATM helped to preserve cash, but look at the PPS. Do they even have any guideline for Cowen not to sell ATM? I hope they do. ATM is putting a glass ceiling for PPs and making OCRX difficult to raise money. It will be very interesting to see what a successful P1 will do for pps. Will Ocrx get the chance to raise money other than ATM?
OCRX sold 600,000 sh in Feb.
from 10K
During the year ended 2015, we sold an aggregate of 946,497 shares of common stock under the Sales Agreement, at an average price of approximately $3.95 per share for gross proceeds of $3.74 million and net proceeds of $3.45 million after deducting commissions and other transactions costs. As of December 31, 2015, $21.26 million of common stock remained available to be sold under the Sales Agreement, subject to certain conditions specified therein. In February 2016, we sold an aggregate of 600,000 shares of common stock under the Sales Agreement, at an average price of approximately $3.00 per share, for gross proceeds of approximately $1.8 million.
CEO purchased 3000 sh at $3.19 on Mar.4,2016
May be selling is done for now, but OCRX still has $20 million more to sell.
ESPR up 15% After Hour.
Any info?
IR said they will do P3 on their own. as of 1/3/16.
OCRX
No volume trading following big day yesterday,
I wished for more volume followed by some news, like partnership.
No explanations could be found in public domain.
I feel comfortable holding OCRX as it's MOA is simple as you said and vindicated by Ravicti.
ACAD also had same thing.
Abrupt departure of CMO and a director followed by a downgrade.
I began to think if Alzheimer trial is not going well since this happened after they announced a plan to delay the study.
http://biz.yahoo.com/e/151106/acad8-k.html
OCRX
STOP-HE
I am concerned about significant decline in enrollment rate for the last 2 quarters. Any explanations?
With this rate, the enrollment may not be completed till 2017.
Oral 002
Were they able to secure second $10M debt facility with current P1 out?
Do they need more successful re-do P1 next year to qualify for this?
Financing seems to be a big issue, knowing there is no big catalysts in near term.
I e mailed IR,waiting for the reply.
TIA
Samsung Bioepis
Is there any way to invest in this now? I heard IPO is next year.
OCRX Please help.
1. P1 oral 002 is a positive development since it showed successful delivery of active compound into circulation.
2. higher serum concentration than Ravicti.
3.IV 002 has indication in the setting of HE in ICU when pt can not take oral medication, ie acute GI bleeding, or rapid resolution of HE is financially feasible by shortening of LOS. It can be used in any inpatient He if price can be adjusted. Pt can go home with oral 002 later.
4. Oral 002 can be combined with lactulose or Xifaxsan since the mode of action is totally different, barring there is no adverse interaction or absorption issue.
5. QD formula is crucial for oral 002 to gain the market share as maintenance therapy. compliance is one of the biggest issue here.
6. erratic serum concentration? Is it that much of problem? Rate limiting steps are metabolism in the muscle and excretion through kidneys. As an endogenous compound, does high peak level cause toxicity? does low trough level cause sub optimal reduction of Ammonia level? My "assumption" is oral preventive therapy may require far lower concentration than acute IV therapy. How much of difference in terms of Ammonia clearance capacity is there? Liver vs muscle? Which pathway is more effective target to prevent HE in the absence of Liver? Reducing production and absorption vs enhancing muscle metabolism? TIA
FMI
Third Rock is out completely?
Does Borisy Alexis have 6.6 million shares (20%)?
It seems like he didn't tender any of his holdings.
Roche has 60%.
I wonder how shorts will cover.
Isn't CA surcharge = 10% no matter what , right ?
FMI - huge sell off after ER.
NO progress in reimbursement issue?
Slow uptake in private sector without further coverage.
Dew, Are you still optimistic for CMS coverage this year?
TIA
Medicare pays to the hospitals according to preset number of days allowed under DRG system. 6.2 days are from my case manager who has the list for our region. Other metabolic or anoxic encephalopathy carry DRG slightly over 10 days. CMS seems to under pay for HE under current DRG system.
The dollar amount reimbursement per day is different from one region to another.
$2000/day for a telemetry bed. HE meeds tele monitoring most likely.
Most HMO may settle contract with local hospitals per diem provided they have reasonable volume to ask for discount.
One of our local hospital gets paid as low as $1600 per day for telemetry bed from medicaid based HMO. (ceo of our hospital)
$1300 per day for OCR quoted from OCRX slide.
Sorry I don't have any better explanation for now.
FYI, I am an intendivist and serve as a chair in Utilization Committee in our local hospital in LA area. Thanks, Dew.
OCR-002 oral
There is not much information I can find.
What will be the transferring vehicle to pass GI absorption.
Will it be possible to achieve therapeutic serum level comparable to iv?
Do they have formulation already? or just saying it will be developed.
TIA
OCR-002 IV
Indication is very limited ie, HE with acute GI bleed where you can not use lactulose. Most HE requiring ICU admission have concomitant multi organ failure,most of them may have acure/chronic renal insufficiency. Simple decompensated HE will be admitted to Telemetry with lacruloose therapy vis naso gastric tube. MS-DRG for HE is 6.2 days. Average Tele costs about $2000 a day. OCR-002 costs $1300/day. Saving one day over SOC may not justify it's use in general. IV 002 may not generate huge revenue but it's success is absolutely needed for OCRX to survive and oral 002 to be successful.
Real potential resides in oral maintenance therapy competing with Ravicti.
High risk though.
The schedule to complete enrollment is again pushed for total 6 Q.
Not easy to find right candidates despite of 100 enrolling centers!
It will be very interesting how management team will resolve financing issue.
Thanks again
OCRX Please help.
FMI -
Biotech sell off.
little earlier then last year.
Those in cash will find good entry with this.
thx Dew,eom.
CT confidential treatment order
What's this all about? Please any one.
IanfromSI
"Dew
Ian fron SI has posted a couple times regarding Roche possibly walking away from deal.You have stated"chances are close to nil" that can happen.Has your % of that happening changed at all?If not,should he be able to continue to post the same ridiculous prediction over and over"
I try not to see things always the only way I want to see.
Different opinions should be respected as well on this board,imo.
I may say Roche may sweeten the tender offer or buy whole FMI as well.
Credibility is serious issue here!
How long has it been since P3 came out?
How many times NDA schedule was postponed?
How many times have we heard reassurance from CC's and presentations?
When was the last confirmation from ACAD about NDA?
How long do you think ACAD has been aware of this manufacturing concern?
Yeah, right! Just a day or two.....
No problem with FDA! Really? I mean "Really"?
Year end was indeed 2015, not 2014. My Bad! :}
ACAD PR seems to be as reliable as Sierra report or Seeking Alpha!
I began to believe Pima is in wrong hands!
How is HCV different from HBV?
Hep C
85% of infected will develop chronic disease.
15% will have occult disease either free of virus or low viral load with normal liver enzymes.
Effective treatment is available.
common in western society, North of Sahara and Japan.
No vaccination available.
Diagnosed as Hep C if you are positive for antibody against Hep C.
Dew mentioned some ABBV exclusive contract allow V-Pak for ALL hep C patients, Not limited to symptomatic patients only like GILD contracts.
Hep B
90% of infected are self limited with immunity naturally acquired,
10% will develop chronic Hep B.
Vertically transmitted will likely progress into chronic Hep B.
Hence, prenatal screening and vaccination is emphasized.
Vaccination is easily available.
No break through cure is available. IDIX and NVS had developed "TYZEKA" in 2006 with dismal efficacy and commercial success. Not sure if NVS still has this.
Hep B is endemic in Asia and Sub-Sahara.
I hope my memory served me right. Please feel free to correct me.
Does anyone on this board care to give any plausible excuses for ABBV not to take over ENTA other than price concern? Or all it matters is "the price" after all?
HCV Medicaid
Also NY,CT,FL for V-Pak.
http://www.bidnessetc.com/33608-will-gilead-sciences-inc-be-affected-as-missouri-sides-with-abbvie-abbv/
The disparity in estimated V-pak value between Enta and Abbvie has decreased considerably with recent drop in pps. Enta is lean and prepped for BO this year,IMO. Dropping macrolide antibiotic program was a good move. I think Nash program is just for a show. I believe Abbvie's marketing strategy targeting under-served population was inevitable to capture this market. These third party payors are extremely sensitive in terms of cost of the goods if efficacy is comparable. This is only way to compete against almost perfect product. I did heavy buying recently expecting pleasant surprise in next 2 quarters.
FMI Tender or Not to?
Holding all my shares in taxable account for LT gain.
Will it go up or down after tender offer completed?
If the price action is good with smaller float and new pipeline/reimbursement, I may hold through complete BO.
No risk of dilution for some time.
I think it is relatively safe?? bet like ENTA.
FMI re: tender offer. FYI.
Charles Schwab sent out notifications to the FMI share holders to tender by FEB 26.
E TRADE and Scottrade did not.
FMI: possible negative impact on Pharma revenue.
ILMN teamed up with 3 BP's last summer, but I am not aware of any pharma in competition with these bP's walked away from ILMN.
FMI mentioned about "firewall" to retain existing pharma partners.
I absolutely agree pharmas are concerned about their trade secrets being kept confidential. Partial buy out will minimize such risks,imo.
FMI Dew May I ask a few questions?
1.What will be the impact with Roche on testing numbers in 2015?
You previously estimated 40K in 2015.
2.Likely chance of over-subscription?
FMR alone has more than 3M shares.
3.CMS coverage by Q3?
Will it be likely with partial indication for metastatic lung cancer with undetermined primary at the time of biopsy?
4.Would you consider to revise your valuation model after C.C.?
Tender offer schedule expected
Starting on 2/1/15.
for 6 weeks likely.
Ending mid Mar.
Proxy vote during yr ending ER in late Feb.
Cash pay out around 3/20/15 if there is no need for extension.
Once you tender your shares, you will not be able to trade those shares in open market unless you withdraw.
How to tender? just call your broker on the phone same day.
How to withdraw? takes a couple of days.
When to tender? No need to hurry. you may wait till last minutes. Wait for CC and decide. Acceptance is pro rated, nor first come first served.
Dr.Pellini previously said they were debating whether to develop "technology" internally or to acquire start-up co.. I believe he was referring to "liquid biopsy".
Dew
Got it!
For other buy out case, I got proceedings posted to my account next day.
Based on your reply, I may tender mine and need to wait till the closure of offer period. sort of my share locked from trading.
FMI said tender will commence later this month.
What would be conventional duration of offer period?
DEW RE: FMI—Bear in mind that if the tender offer is oversubscribed, you will get only a partial fill
Partial fill can be no less than 50% if all outstanding shares are tendered.
What would be the criteria to assign acceptance to tendered shares?
first come, first served?
Is there any restriction for Roche to trade floating shares obtained through this tender offer?
I am completely ignorant to this type of deal.
Thanks!
I have a plan to tender my share in retirement account.
FMI Holders - I'm one - Selling or staying? EOM
I decided to stay.
Tax reason.
Safe - not a drug developer. low cash burn, $300 million cash.
New pipeline- liquid biopsy and immuno-oncology.
Unlimited resource for R&D and marketing infra-structure from Roche.
Not a mandatory tender offer.
Roche may or may not achieve more than 50% shares with this offer.
Roche may do same thing like they did for Genentech.
Excellent track record of business execution by Mr.Pellini
Dew said "possibly higher upside"
The deal is very much in favor for current insiders.
Roche’s analysis is consistent with my (Aug2014) valuation model
Dew
Do you think there is more upside from this level?
Thanks again.
Dew Thank You.
This is the best deal ever!
In view of privatization of Genentech by Roche, I am considering holding my shares for the further gain and long tern tax purpose.
FMI can be huge in in oncology field, tapping into global market.
Immuno-pathology and liquid biopsy fields as well.
Unlimited resources and mega infra-structures.
FMI now has WINGS!
ROCHE
YES
Done with "buying at the dip"
I don't expect secondary offering at $20,IMO.