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Saturday, 10/08/2016 10:55:41 AM

Saturday, October 08, 2016 10:55:41 AM

Post# of 1794
NEWS RELEASE/ 5:53 pm Novo Nordisk A/S receives Complete Response Letter
http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#ogzpy
NVO
from the FDA regarding the New Drug Application for faster-acting insulin aspart (NVO) : In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the New Drug Application can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to resolve the outstanding issues.
TWLO
5:17 pm Twilio confirms filing for a proposed follow-on public offering of shares of its Class A common stock, affirms that a majority of the shares in the proposed offering are expected to be sold by existing stockholders (TWLO) :
CWCO
5:16 pm Consolidated Water updates on the impact of Hurricane Matthew on the operations of its subsidiaries Consolidated Water (Bahamas) Ltd. and Aerex Industries, Inc. (CWCO) :

"We have assessed the condition of our water production facilities in Nassau, The Bahamas and our other businesses in Florida after the passing of Hurricane Matthew.

Our largest plant at Blue Hill Road sustained only minor damage to the building and continued to run throughout most of the storm. The plant was shut down for safety reasons late yesterday morning but is now operating again using our standby electrical generator. Our second plant at Windsor Field, which is significantly older than our Blue Hill Road plant, sustained damage to its building and we are currently working to restore that plant to operating condition. Although we are still receiving reports from our staff and customer in Nassau, our current understanding is that homes and businesses in Nassau sustained significant damage from wind and flooding....Fortunately our subsidiary Aerex Industries in Ft. Pierce, Florida and our administrative office in Coral Springs, Florida did not sustain any damage from the hurricane and our personnel at these locations returned to work today."
5:09 pm Ellington Financial reports its estimated book value per common share as of September 30 was $20.12, or $19.84 on a diluted basis (EFC) :
MYL
4:45 pm Mylan N.V. agrees to settlement on Medicaid rebate classification for EpiPen Auto-Injector, lowers FY16 EPS guidance (MYL) :

The co announced that its subsidiary, Mylan Inc., has agreed to the terms of a $465 million settlement with the U.S. Department of Justice and other government agencies that will resolve questions that have been raised about the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program.

The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc. or any of its affiliated entities or personnel. The question in the underlying matter was whether EpiPen Auto-Injector was properly classified with the Centers for Medicaid and Medicare Services as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government. The settlement terms provide for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for CMS purposes and subject to a higher rebate formula. In connection with the settlement, Mylan expects to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Mylan will continue to work with the government to finalize the settlement.
Updated guidance:
The co stated that it now sees FY16 EPS of $4.70-4.90 vs. prior guidance for $4.85-5.15 and vs. the $4.95 Capital IQ Consensus Estimate
The majority of this change in full year 2016 adjusted EPS guidance is the result of the previously announced changes in EpiPen Auto-Injector access programs and the upcoming launch of the generic to EpiPen Auto-Injector. These initiatives seek to further enhance access to, and affordability of, EpiPen Auto-Injector. Much of the impact of this guidance change will occur in the third quarter.
Mylan says it remains committed to its target of at least $6.00 in adjusted EPS in 2018.
The co stated that it now sees FY16 EPS of $4.70-4.90 vs. prior guidance for $4.85-5.15 and vs. the $4.95 Capital IQ Consensus Estimate
The majority of this change in full year 2016 adjusted EPS guidance is the result of the previously announced changes in EpiPen Auto-Injector access programs and the upcoming launch of the generic to EpiPen Auto-Injector. These initiatives seek to further enhance access to, and affordability of, EpiPen Auto-Injector. Much of the impact of this guidance change will occur in the third quarter.
Mylan says it remains committed to its target of at least $6.00 in adjusted EPS in 2018.
4:16 pm Pzena reports preliminary assets under management as of September 30 of $27.4 bln vs. $27.6 bln at the end of August (PZN) :
WRAPX
4:16 pm Closing Market Summary: Stocks End Flat with Rates and Employment Data in Focus (:WRAPX) :

The stock market finished a range bound week on a relatively flat note as investors pored over the Employment Situation Report for September. Interest rate volatility remained at the forefront as participants assessed an evolving fed funds rate hike picture and further Brexit shocks from across the pond. The Nasdaq Composite (-0.3%) settled in-line with the S&P 500 (-0.3%) and slightly behind the Dow Jones Industrial Average (-0.2%).

Long-term interest rates struggled for direction as a mixed reading from the September employment report shifted the U.S. rate hike outlook. Headline nonfarm payrolls increased by 156,000
(http://www.Briefing.com consensus 176k) while August's reading was revised to 167,000 from 151,000. Furthermore, average hourly earnings increased by 0.2% (Briefing.com consensus +0.2%), which could pave the way to an increase in inflation expectations. Average hourly earnings growth also registered the largest year-over-year increase in several years.

The fed funds futures market responded by discounting the odds of a November rate hike and improving the outlook for a December hike. The implied probability of an interest rate hike at the December meeting increased to 69.5% from 63.4% in the prior session. Rate hike odds also improved as participants assessed remarks from Cleveland Fed President Mester (an FOMC voter) and Fed Vice Chair Fischer. President Mester stated that the employment report appeared consistent with her expectations while Mr. Fischer called the reading a "Goldilocks number."

The benchmark index finished in the middle of its trading range, testing technical resistance near the 2155 price level. Nine sectors ended in the red with materials (-1.8%), industrials (-1.2%), and consumer discretionary (-0.4%) acting as notable laggards. On the flipside, financials (+0.1%) and health care (+0.1%) settled in positive territory.

In the heavyweight industrials sector (-1.2%), Honeywell (HON 106.94, -8.67) tumbled 7.5% after projections for its third and fourth quarter fell short of analyst estimates. Meanwhile, Dow component United Technologies (UTX 100.58, -1.50) finished at the bottom of the price-weighted average as it moved lower in sympathy with the name. The broader sector declined 1.4% this week, which compares to a loss of 0.7% in the benchmark index.

The Dow Jones Transportation Average (-0.9%) displayed relative weakness as airlines trimmed their weekly advance. The U.S. Global Jets ETF (JETS 23.09, -0.35) declined by 1.5%, erasing its weekly gain.

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