UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 3, 2014
Minerva Neurosciences, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36517 | 26-0784194 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 1601 Trapelo Road | ||
| Suite 284 | ||
| Waltham, MA | 02451 | |
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code): (617) 600-7373
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events |
On December 3, 2014, Minerva Neurosciences, Inc. (the “Company”) announced the completion of its development and final selection of a once-daily dose formulation of MIN-101 for its schizophrenia program. The new formulation will be used in the Company’s planned Phase 2b clinical trial in schizophrenia, scheduled to begin recruiting in the first half of 2015.
A copy of the Company’s press release regarding the information referenced above is filed as Exhibit 99.1 to this Current Report on Form 8-K.
A copy of the Company’s updated corporate presentation that includes supporting data for the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit |
Description | |
| 99.1
99.2 |
Press Release issued by Minerva Neurosciences, Inc., dated December 3, 2014.
Presentation of Minerva Neurosciences, Inc. | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MINERVA NEUROSCIENCES, INC. | ||
| By: | /s/ Mark S. Levine | |
| Name: | Mark S. Levine | |
| Title: | Vice President, General Counsel and Secretary | |
Date: December 3, 2014
INDEX OF EXHIBITS
| Exhibit |
Description | |
| 99.1
99.2 |
Press Release issued by Minerva Neurosciences, Inc., dated December 3, 2014.
Presentation of Minerva Neurosciences, Inc. | |
Exhibit 99.1
MINERVA NEUROSCIENCES ANNOUNCES COMPLETION OF DEVELOPMENT
AND FINAL SELECTION OF ONCE-DAILY DOSE FORMULATION OF MIN-101 FOR ITS
SCHIZOPHRENIA PROGRAM
New formulation to be used in planned Phase 2b clinical trial has been developed to offer improved safety, tolerability and pharmacokinetic profile
WALTHAM, Mass., December 3, 2014 (GLOBE NEWSWIRE) – Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat neuropsychiatric diseases and disorders, today announced the completion of development and final selection of a once-daily dose formulation of MIN-101, an antagonist on 5-HT2A and Sigma2 receptors for the treatment of schizophrenia. The new formulation will be used in the Company’s planned Phase 2b clinical trial in schizophrenia, scheduled to begin recruiting in the first half of 2015.
“The development and final selection of this once-daily formulation of MIN-101 represents an important milestone in our plan to develop a formulation of MIN-101 to achieve optimal efficacy, safety, tolerability and pharmacokinetic profiles,” said Dr. Remy Luthringer, chief executive officer and president of Minerva. “We are especially encouraged by the pharmacokinetic parameters of this formulation and believe it has the ability to address significant areas of unmet need in the treatment of negative symptoms, cognitive impairments and sleep disorders.”
The administration trial objectives were to develop a formulation of MIN-101 to allow for chronic daily administration by maintaining daily exposure of the compound and keeping the maximum plasma concentration (Cmax) and its two active metabolites (BFB-520 and BFB-999) below a level based on previous pharmacokinetic/pharmacodynamics analyses. The trial results show that the final formulation of MIN-101 lowers levels of BFB-520, which has been previously associated with prolongation of QT intervals at supra-therapeutic levels.
“We believe that this new once-daily formulation will be able to maintain plasma levels of MIN-101 over the course of one day while reducing BFB-520 levels and increasing levels of BFB-999 associated with sleep improvements due to its affinity to 5-HT2A and histaminergic H1 receptors,” added Dr. Luthringer.
About The Study
The new formulation was assessed in a single-center, open-label trial to evaluate the safety, tolerability and pharmacokinetic profiles of several formulations of MIN-101 in a single dose administration setting. Plasma levels of parent compound MIN-101 as well as of the two main metabolites (BFB-520 and BFB-999) were assessed in 12 young healthy volunteers, who received three different formulations of MIN-101. Six adverse reactions of mild to moderate intensity were reported in five subjects: sleepiness (2); headache (3); and blurred vision (1). QTc measures stayed in the recommended values as given by ICH-E14 on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs.
About Schizophrenia
Patients suffering with schizophrenia can present with a range of symptoms, including: positive symptoms, such as delusions, hallucinations, thought disorders, and agitation; negative symptoms, such as mood flatness and lack of pleasure in daily life; cognitive symptoms, such as the decreased ability to understand information and make decisions, difficulty focusing, and decreased working memory function; and sleep disorders. Most currently approved therapies for schizophrenia show efficacy primarily in the management of positive symptoms. An estimated 4.2 million people suffered from schizophrenia in 2012 in the United States and the five major European Union markets. Of those, an estimated 48% experienced predominantly negative symptoms and 80% suffered from cognitive impairment. In addition, about 50% of patients with schizophrenia experience sleep disorders, which can further exacerbate both positive and negative symptoms.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat neuropsychiatric diseases. Minerva is developing a portfolio of first-in-class proprietary compounds, including lead compound MIN-101, which is in Phase 2 trials for schizophrenia, and additional candidates targeting major depressive disorder (MDD), insomnia and other CNS disorders. Minerva’s common stock is listed on the NASDAQ Global Market where it trades under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com/.
Forward-Looking Safe-Harbor Statement:
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the benefits, efficacy and safety of the new once-a-day formulation of MIN-101; timing and results of future clinical milestones; the timing of future clinical trials and results of such clinical trials regarding MIN-101; clinical and therapeutic potential of MIN-101 and our ability to successfully develop and commercialize MIN-101; and management’s ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-101 or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether MIN-101 and our other therapeutic products will be successfully marketed if approved; whether any of our other therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the Securities and Exchange Commission on November 6, 2014. Copies of reports filed with the SEC are posted on our website. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.
CONTACT:
Media Contact:
David Salisbury
Berry & Company Public Relations
Tel: 212-253-8881
dsalisbury@berrypr.com
Investor Contact:
Renee Leck
Stern Investor Relations
Tel: 212-362-1200
renee@sternir.com
Source: Minerva Neurosciences, Inc.
 Exhibit 99.2
Minerva Neurosciences, Inc.
1601 Trapelo Road, Suite 284, Waltham, MA
02451 |
 2
Forward-Looking Statement Safe-Harbor
All trademarks, trade names and service marks appearing in this presentation are
the property of their respective owners. This presentation contains certain forward-looking
statements about Minerva Neurosciences that are intended to be covered by the safe harbor for
“forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts. Words such as
“expect(s),” “feel(s),” “believe(s),” “will,”
“may,” “anticipate(s)” and similar expressions are intended to identify
forward-looking statements. These statements include, but are not limited to: the benefits,
efficacy and safety of the new once-a-day formulation of MIN-101; the timing and results of
future clinical milestones; the timing of future clinical trials and results of such clinical trials;
statements regarding our ability to successfully develop and commercialize our therapeutic
products; our ability to expand our long-term business opportunities; our expectations
regarding approval for our products by the U.S. Food and Drug Administration or equivalent foreign regulatory
agencies; estimates regarding the market potential for our products; financial projections and
estimates and their underlying assumptions; and future performance. All of such statements are
subject to certain risks and uncertainties, many of which are difficult to predict and
generally beyond the control of the Company, that could cause actual results to differ materially from
those expressed in, or implied or projected by, the forward-looking statements. These risks and
uncertainties include, but are not limited to: the benefits, efficacy and safety of the new
once-a-day formulation of MIN-101; the timing and results of future clinical
milestones; the timing of future clinical trials and results of such clinical trials; whether any of our therapeutic candidates
will advance further in the clinical trials process and whether and when, if at all, they will receive
final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory
agencies and for which indications; whether any of our therapeutic candidates will be
successfully marketed if approved; whether our therapeutic product discovery and development
efforts will be successful; our ability to achieve the results contemplated by our collaboration
agreements; the strength and enforceability of our intellectual property rights; competition
from pharmaceutical and biotechnology companies; the development of and our ability to take
advantage of the market for our therapeutic products; our ability to raise additional capital to
fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our
periodic and interim reports filed with the Securities and Exchange Commission which are available on
the SEC website at www.sec.gov. Our audience is cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof, and we do not undertake
any obligation to revise and disseminate forward-looking statements to reflect events or
circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. |
 Minerva:
Overview R&D Current Status 3
Subject to additional financing
*
TBC –
subject to Ph1 results
‡
Planning in progress; subject to additional financing
End of bar = expected availability of topline results
Phase / Event
Q1
Q1
Q1
Q2
Q2
Q2
Q3
Q3
Q3
Q4
Q4
2014
2015
2016
Once A Day Formulation
Ph IIB in Schizophrenia
Ph IIB Extension
Parallel clinical development & phase III
preparation
Phase IB in MDD (single dose)
PK/Safety Study in HV (MAD)
BA Study in HV (solid)
Ph IIA in Primary Insomnia
*
Ph IIA in Sec. Insomnia (MDD)
*
Ph II in MDD
‡
MPTP Primate Study
Ph I in Healthy Volunteers
‡ |
 MIN-101
4 |
 R&D update
Once a day formulation results
Phase IIB study design
5 |
 MIN-101C02: Once a day formulation
6
MIN-101C02
Study Title:
A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101
and its Main Metabolites Following Single and Multiple Dose Modified Release
Prototype Formulation Administration in Healthy CYP2D6 Extensive Metaboliser
Male and Female Subjects, and to Evaluate the Relationship Between the
Pharmacokinetic Profile of MIN-101 and its Main Metabolites and
Cardiovascular Parameters |
 7
0
10
20
30
40
Change in QTcF by BFB-520 concentration
Plasma concentration
1
2
3
4
5
6
Change in QTcF by BFB-999 concentration
Plasma concentration
0
50
100
150
Change in QTcF by CYR-101 concentration
Plasma concentration
2 subjects with outlying values removed
Dose adjustment period D2
Dose adjustment period D4
Dose adjustment period D6
Fixed dose period D14
Ambulatory and fixed dose period D28
Exposure levels not to exceed…. |
 Part 1
Study Design 8
PART 1
32 mg
slow
release
32 mg
medium
release
40 mg
slow
release
32 mg
slow
release
Screening
Day -28 to
Day -2
Period
1
Period
2
Period
3
Period
4
Period
5
Period
6
Food
interaction
Follow
up
call 3 to 5
days
after
last |
 Plasma
Concentration-Time Profiles: MIN-101 Linear Scale 9
|
 Plasma
Concentration-Time Profiles: BFB-520 Linear Scale 10
|
 Plasma
Concentration-Time Profiles: BFB-999 Linear Scale 11
|
 C
max
by Period
12 |
 Summary
of Select PK Parameters – Period 1 (32 mg Slow Release, Fasted)
13
MIN-101
Tmax
(h)
Cmax
(ng/mL)
Tlag
(h)
t1/2
(h)
AUClast
(h*ng/mL)
N
10
10
10
9
10
Mean
NA
22.52
NA
6.257
211.9
Median
2.25
23.74
0
5.353
220.4
CV%
NA
28.3
NA
38.1
18.6
BFB-520
Tmax
(h)
Cmax
(ng/mL)
Tlag
(h)
t1/2
(h)
AUClast
(h*ng/mL)
N
10
10
10
4
10
Mean
NA
1.321
NA
6.540
18.60
Median
4
1.294
0.5
6.458
18.04
CV%
NA
27.7
NA
21.1
24.7
BFB-999
Tmax
(h)
Cmax
(ng/mL)
Tlag
(h)
t1/2
(h)
AUClast
(h*ng/mL)
N
10
10
10
5
10
Mean
NA
1.510
NA
6.202
16.02
Median
3
1.436
0.25
5.486
15.22
CV%
NA
19.5
NA
27.3
22.3 |
 Conclusions –
MR Formulation Under Fasted Conditions
14
Short lag time suggestive of fast bioavailability
Exposure variability is generally low
Low to non-quantifiable values for most by Hour 24
PK is generally dose proportional for MIN-101 & BFB-999, and less so for
BFB-520 Inversion of BFB-520 & BFB-999 occurred with generally
suppressed levels of BFB- 520, and a higher BFB-999 to BFB-520
ratio MR formulation findings suggest shorter time in small intestine is helpful
in suppressing BFB-520 levels
Halflife for MIN-101 and 2 metabolite in 3-8 hour range, longer for 40 mg slow
release most likely due to flip-flop (absorption & elimination balanced
during terminal phase) Simulation results indicate steady state within 10-14
days, and no accumulation for all 3 analytes |
 Conclusions –
Food Effect
15
Positive food effect evident –
Higher exposure
MR formulation behaved similar to IR formulation with rapid release and absorption,
mostly prior to reaching colon
•
This explains further increase in BFB-520 levels
Due to rapid absorption MIN-101 Cmax increase was ~ 2x, BFB-520 Cmax increase
was ~ 3x, and BFB-999 Cmax increase was ~ 0.5x
Halflife was shortened substantially: Fed to Fasted ratios were
•
0.5 for MIN-101
•
0.8 for BFB-520
•
0.6 for BFB-999
Consequently, accumulation is not expected
AUC increase was minimal (compared to Cmax): 1.3 to 1.8 multiples with highest
increase to BFB-520 |
 16
32 mg slow release in fasted condition
will be the formulation used in the C03 upcoming patient
study in patients suffering from schizophrenia
Conclusion |
 QBR117055_ MIN-101C02
17
Study Part 2:
16 and 32 mg will be explored
Screening
Day -28 to
Day -2
Period 1
Period 2
Period 3
Follow
up
visit
5
days
after
last dose
of IMP |
 18
Period Scheme
•
Admission
•
Dosing, PK profile and ECG/vital sign
s
•
Dosing
•
Dosing; sleep
at 22:00
•
Dosing; PK profile, Triplicate
ECGs
•
Discharge
24h post dose
•
Optional
visit
(PK 48 h post dose)
Day -1
Day 1
Day 2-5
Day 6
Day 7
Day 8
Day 9 |
 MIN-101C03:
Phase
IIB
in
patients
suffering
from
schizophrenia
19
MIN-101C03
Study Title:
A Phase IIb, Multi-centre, Randomized, Double-blind, Parallel-group,
Placebo-controlled Study to Evaluate the Efficacy, Tolerability and Safety
of MIN-101 in Patients with Negative Symptoms of Schizophrenia
Followed by a 24-week, Open-label extension. |
 MIN-101C03: Phase IIB in patients with schizophrenia
20
Screening
Wash out
Period
Baseline
Core Study
Treatment period (12 weeks): MIN-101 (64 or 32 mg) or
PLACEBO
Extension
6-month: MIN-101 64 or 32 mg
Obligatory In patient Day -3 to day +2 afterwards
up to the end of study at the discretion of the PI
A
A
IN
A
IN
A
D-21
D-3 to D-1
Day-1
D1
D2
W2
W4
W8
W12
W
14
W
18
W
24
W
30
W
36
W
37
V1
V2
V3
V4
V5
V6
V7
V8
V9
V
10
V
11
V
12
V
13
V
14
V
15
Global Study Design
RANDOMIZATION |
 MIN-101C03: Phase IIB in patients with schizophrenia
Study Objectives
21
Primary
To evaluate the efficacy of MIN-101 compared to placebo in
improving the negative symptoms of schizophrenia as
measured
by
the
change
from
Baseline
in
the
Positive
and Negative Syndrome Scale (PANSS) negative
subscale score of the pentagonal model over 12 weeks
of treatment. |
 MIN-101C03: Phase IIB in patients with schizophrenia
Study Objectives
22
Main Secondary
•
To evaluate the efficacy of MIN-101 compared to placebo in improving other
symptoms of schizophrenia as measured by the change from baseline in the
PANSS
total
score,
and
sub-scores
of
the
pentagonal
model
AND
3
factors
analysis
over
12
weeks
of
double
blind
treatment.
•
To evaluate the efficacy of MIN-101 compared to placebo in improving
negative symptoms of schizophrenia as measured by the change from
Baseline
in
the
Brief
Negative
Symptoms
Scale
(BNSS)
total
score
over
12
weeks of double blind treatment.
•
To assess the effects versus placebo of MIN-101 on cognitive function as
measured
by
the
Brief
Assessment
of
Cognition
in
Schizophrenia
(BACS)
battery over 12 weeks of double blind treatment.
•
To assess the persistence of efficacy, and the safety and tolerability of
MIN- 101 during the 24-week, of open-label extension phase.
|
 MIN-101C03: Phase IIB in patients with schizophrenia
Study Objectives
23
Exploratory objectives
•
To
evaluate
the
effects
versus
placebo
of
MIN-101
on
depressive
symptoms
as
measured
by
the
Calgary
Depression
Scale
for
Schizophrenia (CDSS) over 12 weeks of double blind treatment.
•
To
evaluate
the
effects
versus
placebo
of
MIN-101
on
social
functioning
by
means
of
the
Personal
and
Social
Performance
(PSP) over 12 weeks of double blind treatment.
•
To
assess
the
effects
versus
placebo
of
MIN-101
on
sleep
architecture
and
continuity
as
measured
with
the
help
of
the
V-Watch
methodology
over
12
weeks
of
double
blind
treatment. |
 MIN-101C03: Phase IIB in patients with schizophrenia
Inclusion/ Exclusion Criteria
24
Main Inclusion Criteria
•
Male or female patient, 18 to 60 years of age, inclusive.
•
Patient meets the diagnostic criteria for schizophrenia as defined in the
Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition
(DSM-V) •
Patient being stable in terms of positive symptoms over the last three
months according to his treating psychiatrist
•
Patient presenting with negative symptoms over the last three months
according to his treating psychiatrist
•
Patient with PANSS negative sub-score of at least 20.
•
Patient with PANSS item score of <4
on: P4 Excitement, hyperactivity P7
Hostility P6 Suspiciousness G8 Uncooperativeness G14 Poor impulse control
•
No change in psychotropic medication during the last month
•
Patient must be extensive metabolizers for P450 CYP2D6, as determined by
genotyping test before the first drug dose is administered.
|
 MIN-101C03: Phase IIB in patients with schizophrenia
Inclusion/ Exclusion Criteria
25
Main Exclusion Criteria
•
Current bipolar disorder, panic disorder, obsessive compulsive disorder, or
evidence of mental retardation.
•
Patient’s
condition
is
due
to
direct
physiological
effects
of
a
substance
(e.g.,
a
drug
of
abuse, or medication) or a general medical condition.
•
Significant risk of suicide or attempted suicide, or of danger to self or
others. •
Patient
who
cannot
be
discontinued
from
psychotropics
other
than
those
allowed.
•
Patient who received clozapine within 6
months of the Screening visit.
•
Patient receiving treatment with depot antipsychotic medication can be enrolled in
the study 4 weeks after the last injection.
•
Patient with a history of significant other major or unstable neurological,
neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological,
pulmonary, cardiovascular, metabolic, gastrointestinal, or urological
disorder. •
Patient with a clinically significant electrocardiogram (ECG) abnormality that
could be a safety issue in the study, including QT interval value corrected
for heart rate using the
Fridericia’s
formula
(QTcF)
>
430
msec
for
males
and
>
450
msec
for
females. |
 MIN-101C03: Phase IIB in patients with schizophrenia
Assessments
26
Main Efficacy Assessments
–
Positive and Negative Symptoms Scale (PANSS)
–
Brief Negative Symptoms Scale (BNSS): semi structured interview, designed to
measure the current level of severity of negative symptoms in schizophrenia and
schizoaffective disorder (Kirkpatrick et al.)
•
Anhedonia
•
Distress
•
Asociality
•
Avolition
•
Blunted affect
•
Alogia
–
Brief Assessment of Cognition in Schizophrenia (BACS)
–
Personal and Social Performance (PSP): assess social functioning;
clinician rated –
socially useful activities,
–
personal and social relationships,
–
self-care
–
disturbing and aggressive behavior
–
Sleep architecture and continuity |
 MIN-101C03: Phase IIB in patients with schizophrenia
-
Sleep assessment
27
WHY?
–
Sleep and circadian rhythm disruptions are reported in 30% to 80% of patients with
schizophrenia.
–
Patients with insomnia report •
lower quality of life
•
greater symptom severity
•
worse adherence/compliance to treatment –
Sleep disturbances have also been associated with enhanced psychosis –
Sleep is important for memory consolidation, thus disturbances in sleep architecture,
or circadian de-synchronization could also contribute to the cognitive
impairment observed in schizophrenia. –
MIN-101 showed effects on sleep architecture in the previous Phase 2a study that
could possibly be linked to the improvements observed on negative symptoms and
cognition, thus they will be further investigated in the present study. •
In a subgroup of patients (20) who underwent sleep recordings (PSG), sleep was
evaluated at Baseline and Day 14. MIN-101 had an effect on –
Slow Wave Sleep (SWS) distribution: it shifted SWS from the end to the
beginning of the night: MIN-101 significantly increased SWS in the first
third of the night and decreased it in the last third of the night.
–
Sleep initiation parameters (sleep onset latency, latency to persistent sleep).
•
Subjective sleep quality as measured by PSQI improved and this improvement was greater
with MIN-101 than with placebo although not statistically significant. |
 Monitoring sleep in MIN-101C03 using
V-Watch, a
sleep biomarker & companion diagnostic tool
28
PSG
VWATCH
VWatch methodology overview-2 |
 The
Submissions Status is: (1) 29
Romania (22 sites):
End November / Beginning December
Russia (11 sites):
December
Latvia (4 sites):
December
Estonia (3 sites):
End December/ Beginning January
Bulgaria (3 sites):
January
Ukraine (12 sites):
January |
 30
Thank you |