MSMB Capital Management LLC

11 JUN -7 A9 :38
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
CITIZEN PETITION
The undersigned submits this petition on behalf ofMSMB Capital Management LLC
("MSMB") in accordance with section 505(q) of the Federal Food, Drug, and Cosmetic Act
("FDCA") and 21 C.F.R. $ 10.30 to request that the Commissioner of the Food and Drugs take
the actions described below.
I. Actions Requested
MSMB respectfully requests that the Food and Drug Administration (FDA) refrain from
approving and refrain from considering approval of investigational radioactive sentinel lymph
node detection agent s without accompanying data from successful controlled trials of such
agents compared against the standard of care for sentinel lymph node detection, namely, the
combination of radioactive colloid and blue dye. Neoprobe Corporation (Neoprobe) has
announced their intention to submit a New Drug Application (NDA) for their investigational
sentinel lymph node detection agent, "Lymphoseek", without proving equivalence or superiority
to the best available standard of care.
Neoprobe has completed two Phase III clinical trials for Lymphoseek, "NE03-05" and
"NE03-09". Both trials failed to compare the current standard of care to Lymphoseek. As the
best available standard of care is the combination of radioactive colloid and blue dye, and
Lymphoseek would not be synergistic and combinable with radioactive colloid, the study schema
and results are not informative for improving or modifying current best clinical practice.
Neoprobe should conduct a head-to-head study against the best standard of care and the FDA
should enforce this requirement to preserve and protect human healthcare in the United States.
MSMB also respectfully requests that the FDA refrain from approving and refrain from
considering approval of investigational radioactive sentine11ymph node detection agents without
data from controlled trials which employ a reference truth standard, in this case, complete
axillary dissection. While the FDA has already communicated this requirement to Neoprobe,
Neoprobe plans on filing a Lymphoseek NDA without fulfilling this request. The FDA should
reiterate and enforce this requirement by refusing to approve or review for approval the
Lymphoseek NDA.
II. Statement of Grounds
A. Factual Background
1. Lymphoseek
Lymphoseek is the brand name for a mannose-dextran conjugate radio1abe1ed with
Technetium-99m in clinical development by Neoprobe Corporation
l
. In an effort to license
Lymphoseek, Neoprobe initiated two Phase III pivotal trials of Lymphoseek, NE003-0S
2
and
NE003-06
3
. NE003-0S began in June 2008
4
and results were reported in March 2009
5
. NE003
OS was a trial in patients with breast cancer and melanoma, and Lymphoseek concordance with
blue dye was the primary endpoint. There was no control group in this study. All patients
received blue dye as well as Lymphoseek. No "truth standard", a traditional element of
diagnostics trials, which is critical to understanding the risk-benefit profile of a diagnostic, took
place in this study. Axillary dissection is logically the preferred truth standard for sentinel lymph
node detection studies, and has been used successfully in the past
6
.
NE003-06 was initiated in May 2009 and enrollment is ongoing? FDA has informed
Neoprobe that Lymphoseek approval cannot occur without completion of a Phase III trial which
incorporates complete axillary dissection
8
. NE003-06 ostensibly would fulfill this requirement
as the protocol specifies an axillary dissection. Despite the fact the NE003-06 study has not
concluded enrollment, and the projected date of completion is in 2013, Neoprobe insists they will
I A Synthetic Macromolecule for Sentinel Node Detection: 99mTc-DTPA-Mannosyl-Dextran. Vera et al. J Nucl Med
2001;42:951-959.
2 ClinicalTrials.gov Identifier: NCT00671918.
3 Neoprobe Corporate Press Release, May 28
th
, 2009. "Neoprobe's Second Phase 3 Lymphoseek Study
Commences."
4 Neoprobe Corporate Press Release, June 9
th
, 2008. "Neoprobe Corp Commences Lymphoseek Phase 3 Trial".
5 Neoprobe Corporate Press Release, March 19
th
, 2009. "Neoprohe's Phase 3 Lymphoseek Study Achieves Positive
Results",
6 Lymphatic Mapping and Sentinel Lymphadenectomy for Breast Cancer. Giuliano et al. Ann Surg 1994;220:391
401.
7 ClinicalTrials.gov Identifier: NCT00911326.
~ Neoprobe Corporate Press Release, April 8
th
, 2009. "Neoprobe Releases Annual Letter to Shareholders."
imminently file a NDA for Lymphoseek without NE003-06 data. The FDA met with Neoprobe
in or around March 2010
9
. Until this time, Neoprobe had anticipated filing a NDA in early
2010
10
, and then in summer 2010
11
Subsequent to the meeting, Neoprobe initiated a new Phase
III clinical trial 12, NE003-09, and revised their filing timeline for the NDA
I3
for a third time.
The NE03-05 study had a primary endpoint of Lymphoseek concordance with blue dye.
This primary endpoint is meaningless as it fails to compare Lymphoseek to the best available
standard of care, which is blue dye plus technetium-99 sulfur colloid. This open-label,
uncontrolled trial makes it impossible for clinicians and regulators to make judgments on the
relative performance characteristics of Lymphoseek versus the standard of care. For instance, it
is well known that radioactive sulfur colloid, which is similar to Lymphoseek, is superior to blue
dye
14
. This further reduces the real-world legitimacy and integrity of the primary endpoint of
NE003-05 as Neoprobe conducted a head-to-head study of Lymphoseek with the less effective
component of the standard of care, without a reference standard (complete axillary dissection).
2. Public Health Importance of Sentinel Lymph Node Mapping
Sentinel lymph node mapping, dissection and diagnosis is the standard of care for
patients with breast
15
and melanoma
l6
cancer. Correct staging of the axilla allows for more well
informed treatment decisions. It is vital that the agents used to map the lymphatic system are
accurate in determining the true draining sentinel lymph nodes. The combination of technetium
99 sulfur colloid and blue dye is the standard of care relied on for almost two decades. Many
long-term studies have determined the combination of these agents provides a reliable
determination of the cancer status of the axilla17. It is imperative that new mapping agents go
through the same vigorous investigation the medical community has conducted with the current
standard of care. Inappropriate staging of lymphatic cancer status and unnecessary resection of
additional lymph nodes would have dramatic negative consequences for patients with cancer in
the United States.
B. Statutory & Regulatory Background
9 Neoprobe Corporate Press Release, March 11 th, 2010. "Neoprobe Announces Successful Meeting on Lymphoseek
Phase 3 Results".
10 Neoprobe Corporation 2008 Form IO-K (Annual Report).
11 Neoprobe Corporation Earnings Teleconference on November 3
rd
, 2009. Transcript accessed on Bloomberg.
12 Neoprobe Corporate Press Release, July 7
th
, 2010. "Neoprobe Initiates Third Phase 3 Lymphoseek Study."
13 Neoprobe Corporate Press Release, October 6
th
, 2010. "Neoprobe Completes Lymphoseek Pre-NDA Meeting."
14 Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping. Wallace et al. Annals
of Surgical Oncology 2007;14(2):913-921.
15 Intraoperative assessment of sentinel lymph nodes in breast cancer. Layfield et al. Br J Surg 2011 ;98(1):4-17.
16 Sentinel lymph node biopsy for melanoma: critical assessment at its twentieth anniversary. Ross et al. Surg Oncol
Clin N Am 2011;20(1):57-78.
17 Survival analysis and clinicopathological factors associated with false-negative sentinel lymph node biopsy
findings in patients with cutaneous lymphoma. Nowecki et al. Ann Surg OncoI2006;13:l655-l663.
There are two key statutory and regulatory elements governing NDA approval that are
relevant to this petition. First, NDA applicants should be required to compare their
investigational agents to the best available standard of care, especially in indications such as
cancer where treatment staging may have a life-or-death impact. Second, NDA applicants for in
vivo diagnostic agents must conduct a truth standard analysis
l8
or sufficient follow-up to justify
the surrogate nature of a diagnostic's ability to be a specific and sensitive assay, especially in
indications such as cancer where treatment staging may have a life-or-death impact.
1. Control Groups In Pivotal Studies Must Be Relevant
In NE003-05 and NE003-09, patients served as their own control group. This means that
there was no true control group versus investigational group that the statute demands. 21 C.F.R.
3l4.l26(b) is clear in its request for a specific control group cohort.
The FDA has long held the standard of "best current care" as a control group. This policy
secures the agency's public health mandate by assuring newly approved drugs and diagnostics
are attractive treatment options. For example, Lymphoseek availability would confuse clinicians
and payors as to the relative performance of this agent versus standard of care. Approval would
introduce a potentially inferior agent to the hundreds of thousands of sentinel lymph node biopsy
procedures done annually without the rigorous long-term data on cancer recurrence that the
current agents have been scrutinized with.
License status of control group is not relevant to FDA. There are many examples where
the FDA has requested control groups with off-label or non-approved agents. A "physician's
choice" control group for a sentinel lymph node biopsy study would likely result in the majority
of investigators using a combination of radioactive colloid and blue dye. The FDA should not
allow Lymphoseek be compared to a marginalized regimen.
2. Truth Standard Should Be Required For All Radiopharmaceutical
Diagnostics
21 C.F.R. 315.5(b) specifically requests that diagnostic radiopharmaceuticals prove
their "accuracy and usefulness" by "comparison with a reliable assessment of actual clinical
status", which is provided by a "diagnostic standard of demonstrated accuracy." The
combination of sulfur colloid and blue dye is the diagnostic standard of demonstrated accuracy.
21 C.F.R. 315.5(b) further states "in the absence of such diagnostic standard(s), the
actual clinical status must be established in another manner, e.g., patient followup." By not
18
21 C.F.R. 315.5(b).
conducting patient followup, Neoprobe is adding to the risk that physicians will rely on
Lymphoseek without understanding if it fully predicts the axillary status of a patient.
C. Arguments
Investigational new drugs must be controlled in trials against standard of care when a
standard exists
19
. This subsection explains that a standard clearly exists for sentinel lymph node
mapping and Neoprobe is attempting to pursue approval of Lymphoseek without trials against
this standard.
This subsection will also show that radiopharmaceutical diagnostic agents cannot be
meaningfully understood without a truth standard reference, in this case, axillary nodal
dissection. Again, Neoprobe is attempting to license Lymphoseek without including such a truth
standard reference, even though FDA has requested this in the past.
This subsection will also show that the NE003-05 and NE003-09 studies had material
conflicts of interest which may have compromised the integrity of the study. Indeed, open-label,
non-randomized, non-controlled studies are prone to such errors.
Finally, this subsection will show that the FDA has already requested that Neoprobe
conduct a pivotal trial of Lymphoseek with regional nodal dissection truth standard to confirm
the sentinel node biopsy results. By their own requirement, the FDA must wait for these data to
become available before considering approval ofLymphoseek.
1. Current Standards for Sentinel Lymph Node Mapping
The standard of care for sentinel lymph node mapping is the use of a radiotracer
combined with a blue dye
20
2122. Four large clinical trials, including the seminal "NSABP-B32"
study23 which enrolled n=5,611 patients, all used either a radioactive colloid with blue dye or a
radioactive colloid alone. For reasons unclear to us, Neoprobe has chosen to conduct Phase III
trials without comparing Lymphoseek to a radioactive colloid or the combination a radioactive
colloid and blue dye.
19 21 C.F.R. 314.126{b).
20 The Sentinel Node Procedure in Breast Cancer: Nuclear Medicine as the Starting Point. Hindie et al. J Nucl Med
2011;52:405-414.
21 Oral Cavity Squamous Cell Carcinoma and the Clinically NO Neck: The Past, Present, and Future of Sentinel
Lymph Node Biopsy. Coughlin and Resto. CUIT Oncol Rep 2010;12{2):129-135.
22 Drug evaluation: Lymphoseek - Neoprobe's sentinellyrnph node imaging agent for use in cancer patients. Tomas
de Paulis. Current Opinion in Investigational Drugs 2006;7:1100-1107.
23 Primary outcome results ofNSABP B-32, a randomized phase III clinical trial to compare sentinel node resection
to convention axillary dissection (AD) in clinically node-negative breast caner patients. Krag et al. J Clin Oncol June
2010;supp118:LBA505.
In Phase I studies conducted by Neoprobe and collaborators, Neoprobe chose a more
intuitive protocol of Lymphoseek versus sulfur colloid with blue dye in both cohorts
24
25. It is
well-known that radioactive colloids are superior to blue dyes
26
. Therefore, the study schema that
Neoprobe chose for the Phase III "NE003-05" and "NE003-09" studies using the comparison of
Lymphoseek with blue dye, reveal no valuable information to clinicians, patients or regulators.
Even in a paper by Lymphoseek's inventor and noted Neoprobe collaborator, the author, Dr.
Anne W. Wallace, refers to the combination ofisosulfan blue and radiolabeled sulfur colloid as
"standard technique,,27 and uses the combination to compare results with Lymphoseek. Indeed, a
very recent study in a popular medical journal, the authors explain that "in the United States,
lymphoscintigraphy is performed by means of intradermal injection of technetium-99m-Iabeled
sulfur colloid,,28. This is despite the lack of FDA approval for sulfur colloid in this indication.
Yet another recent paper examining Lymphoseek and its derivatives explains "the current
method for sentinel lymph node mapping in melanoma and breast cancer involves injection of a
combination of Isosulfan Blue and a 99m-Tc-labeled colloid radiopharmaceuticat2
9
.
The concordance endpoint is possibly valid if the intent of the "NE003-05" and "NE03
09" studies was to validate the hypothesis of safely replacing isosulfan blue with Lymphoseek.
However, it is clear from the radiolabeled nature of Lymphoseek, it would serve as a
replacement for technetium-99m sulfur colloid only. Because the standard of care is isosulfan
blue plus a radioactive colloid, concordance with isosulfan blue is not meaningful as physicians
would likely not benefit from two radioactive agents. Proving superiority, or even equivalence,
of Lymphoseek against radioactive sulfur colloid would be a useful clinical goal, and FDA
should advise Neoprobe to conduct such studies.
Early, preclinical studies of Lymphoseek by Neoprobe and Dr. Anne Wallace
contemplated the combination use of Lymphoseek with isosulfan blue
3o
This combination usage
could have been a viable comparator with sulfur colloid with isosulfan blue, but the company
moved away from the design of such studies, presumably to avoid the large cost and time of
trialing such studies would require. The FDA should not compromise human healthcare in the
United States because Neoprobe is unwilling to go through an arduous trial with a true control
group.
24 Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek. Wallace et al.
Nuclear Medicine and Biology 2007;34:849-853.
25 Sentinel lymph node accumulation of Lymphoseek and Tc-99m-sulfur colloid using a "2-day" protocol. Wallace,
et al. Nuclear Medicine and Biology 2009;36:687-692.
26 Superiority of Radioisotope over Blue Dye for Sentinel Lymph Node Detection in Breast Cancer. Hayashida et al.
European Surgical Research 2010;44:111-116.
27 Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek. Wallace et al.
Nuclear Medicine and Biology 2007;34:849-853.
28 Sentinel-lymph-Node Biopsy for Cutaneous Melanoma. Gershenwald and Ross. NEJM 2011 ;364: 1738-1745.
29 Fast l8F labeling of a near-infrared fluorophore enables positron emission tomography and optical imaging of
sentinel lymph nodes. Ting et al. Bioconjug Chern 2010;21 :1811-1819.
30 Minimally invasive sentinel lymph node mapping of the pig colon with Lymphoseek. Wallace et al. Surgery
2006; 139:217-223.
2. The Importance of a Reference Standard
Reference standards (sometimes called truth standards) are the raison d'etre of
diagnostics. Without a verifiable, complete and accurate assay, assay sensitivity of a novel
diagnostic cannot be determined. Such an assay exists for sentinel lymph node mapping, and it is
complete axillary dissection followed by pathological evaluation of nodes. Neoprobe has failed
to entertain these basic diagnostic trial design elements, attempting instead to use concordance
with a part of the standard of care to file a NDA. The FDA should not compromise human
healthcare in the United States because Neoprobe is unwilling to move forward with an arduous
trial with a true reference standard.
3. Conflicts of Interest
Dr. Anne Wallace is a primary investigator in at least one of the Phase III pivotal
Lymphoseek studies
3l
. The University of Califomi a San Diego is a study site for both of the
completed Lymphoseek Phase III pivotal studies
32
33. Dr. Anne Wallace's primary affiliation is
with the University of Califomia San Diego, the inventor of Lymphoseek and licensor of
Lymphoseek patents to Neoprobe. Dr. Anne Wallace was intimately involved in the invention of
Lymphoseek
34
35 36. Dr. Wallace and/or University of Califomi a San Diego may have a financial
conflict of interest which would preclude their study center and patients from analysis in the
NE003-05 and NE003-09 studies. The FDA should conduct a study site analysis and determine
if removing the University of Califomia San Diego patients would cause any statistical
significance to be lost in the NE003-05 and NE003-09 studies.
4. FDA Has Requested Truth Standard for Lymphoseek
In a Annual Letter to Shareholders, Neoprobe specifically states:
"While the concept of sentinel node staging of cancer patients with radiolabeled
colloids and vital blue dye products has become widely adopted for breast cancer and melanoma
patients, no such products have been approved as sentinel node targeting agents. Both FDA and
the centralized European regulatory body ( the EMEA) have advised Neoprobe that in
31 Supra note 2.
32 Supra note 2.
33 ClinicalTrials.gov Identifier: NCTOl106040.
34 Supra note I.
35 Supra note 14.
36 Supra note 24.
order to receive a sentinel node product indication for Lymphoseek the drug would need to
be validated in a tumor type where a Lymphoseek directed sentinel node biopsy and a
regional nodal dissection could be performed in the same patient,,37.
The FDA must uphold their prior requirement and consider approval of Lymphoseek
after the NE003-06 study has completed in 2013.
D. Conclusion
In summary, MSMB believes Neoprobe failed to conduct meaningful Lymphoseek
pivotal studies and should be denied to opportunity to receive FDA approval of any NDA for
Lymphoseek, as well as be denied a NDA review opportunity. There is clear evidence in this
petition that suggests NE003-05 and NE003-09 are not informative studies due to their lack of a
control group, a lack of a reference standard and a disregard for the current standard of care for
sentinel lymph node detection.
III. Environment Impact
This petition is categorically exempt from the requirement for an environmental
assessment or an environment impact statement pursuant to 21 C.F.R. 25.31.
IV. Economic Impact
Pursuant to 21 C.F.R. 1O.30(b), an economic impact statement will be submitted upon
request of the Commissioner.
v. Certifications
Pursuant to 21 C.F.R. 10.30(b), the undersigned certifies that, to the best knowledge
and belief of the undersigned, this petition includes all information and views on which the
petition relies, and that it includes representative data and information known to the petitioner
which are unfavorable to the petition.
Pursuant to 21 U.S.c. 355(q)(1)(H), I certify that, to my best knowledge and belief: (a)
this petition includes all information and views upon which the petition relies; (b) this petition
37 Supra note 8.
includes representative data and/or information known to the petitioner which are unfavorable to
the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or
information which are unfavorable to the petition were disclosed to me. I further certify that the
information upon which I have based the action requested herein first became known to the party
on whose behalf this petition is submitted on or about the following date: May 5
th
, 2011. If I
received or expect to receive payments, including cash and other forms of consideration, to file
this information or its contents, I received or expect to receive those payments from the
following persons or organizations: I am a hedge fund manager who will benefit financially from
a decline in the stock price of the corporation developing Lymphoseek, Neoprobe. I am not being
separately compensated for submitting this petition. I verify under the penalty of perjury that the
foregoing is true and correct as of the date of the submission of this petition.
Respectfully submitted,
Martin Shkreli
Chief Investment Officer
MSMB Capital Management LLC
330 Madison Avenue, 6
th
Floor
New York, NY 10017
NEWPacki{Jt

i \[--\r'f'
US Airbili' 8758 6197 5154
1 frolll
/ . ' , Fed: -
J,', {;;' Elf i J\crn '1 I',JUl1IJle c:;A , _ _ , :> a
"'g7 51 _.
t-. j, I /'\
'\i,'I">' '::}hk rtil ..Phone - 'Jlo
',11
I J
/" Ii t" I;
A\.1 I' "
I ,
f'
-1 in
i
/
L.l-G
f
' .
"') i"
.fh CJ
<.. ,\ ',t ;\ I,
'.,J "I",. }" j ld: ... I..J . J ! ,*'
?'. r/
)p.n'..
..I,.,
\
\ j j k" , /\ /'t I -7
,I, IN} f ,. I , State t1\1 llP ! ,.I ,.I /
v.... 'Qternal Billing Reference
3"-j;,
. .
,
R';':ll)'ef'> I I
\ f . .. " I n

'\it: 1r;. V ;" 'D (,,, ;; t I.
f

1 .,
!''', ", I ) .I I " .1 i/ j '-j-'n.""'/1
.' .
HOLD WeeKda'y
FedE.< ildd 'lS,
r<-
''', .'\
....' j' i REQUIRED NOT QVllilable ror
\.'"''
..--' , ,r .. ;. 16,iI I 01 Fir" OVIr1I1'I,",

HOLD Saturday
add""s
REQ'JIREO AvaiIllbl,ONlrltlt
"rJ",,,,, , 31 I f dEx P"JrJlyl},''.lrf1lilm am'
I-edS:2lJwtoselenlor<Jllo'"
1--" __ '" ; . !' ,
f-; r
.", 1.
State . ZIP
..LL"....i:"':-L"::... .;() "I.", '"
1111111111 II III
0200
FedEx Retrieval Copy
4 Express Package Service '0 lSO/b' I
'""OTt StlNll;{' order hilS l.l1i.lflgwl 1:<IHfhuh '1I'
.:ttf1:! .jill}jttj' .Jtf':jlqi.l4jffl.
NEW FedEx 2Day AM
06 X .:' 1\', l" 49 ,1' r O,,(! I "" 1',1'1<:;
:eat",;n" ''dH\,,,!'!l1-o1:)81l!.s't,,o!'J L' v",ed > I\r':!i" fJr/I"I'r,'-Ifjl "If
'1".,;;,
01 03
t-edb ,),;
05 ',ex" 20
5 Packaging dafl'n\:lilIHI'11'It)',l
. ed[" 0'1
06.)("<;0'" ,. <"c. Ot 03 04
B,),\' rUflf'
------,...__._------
6 Special Handllllg and Delivery Signature Options
03 SATURDAY DELIVERY
,I: '.itr
Hj
.:';;:' 34
lines thIS shrllmen1 \;omaIL ddngeioth goads?
IjlWf)' '1IUS'''; clwd/(
.x 0.1 06
CllfqD Aircraft Onh
----_...._---_._- ..._......._-_._------
7 Pavmer:t EMf to
;,.-{t)< til" t. NO or Creliit Card "0. helo,,",
3. rhlrd Party 4 Cre'llt Cal 0 5 Cash/Check
1iri1i.
I
",0-,,,,,",,,""5,,,,,",,,,,'"''''''''
D;;le lilr .;.,' *1f3dbO'[IH94- '010 INUS.A
c:l':Ja 6',S7
1
612
1
L
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
,J.
June 7,2011
Martin Shkreli
Chief Investment Officer
MSMB Capital LLC
330 Madison Ave., 6 h Floor
New York, NY 10017
Dear Mr. Schkreli:
Your petition to the Food and Drug Administration requesting to refrain from approving
investigational radioactive sentinel lymph node detection agents without accompanying
data from successful controlled trials of such agents, was received by this office on
6/7/2011. It was assigned docket number FDA-2011-P-0450-0001/CP, and it was filed
on 06/7/2011. Please refer to this docket number in future correspondence on this subject
with the Agency.
Please note that the acceptance of the petition for filing is a procedural matter in that it in
no way reflects an agency decision on the substantive merits of the petition.
Sincerely,

Division of Dockets Management
Office of Public Information and Library Services
Office of Shared Services
Office of Management
"fJ)If ;LOII p- f) c+ 5()

(" DEPARTMENT OF HEALTH&. HUMAN SERVICES

0''"' cl.-
.
2 2011
Martin Shkreli
8 3 8 9 11 DEC -6 P 4 :55
Chief Investment Officer
MSMB Capital Management LLC
330 Madison Avenue, 6
1
h Floor
New York, NY 10017
Re: Docket No. FDA-2011-P-0450
Dear Mr. Shkreli:
Food and Drug Administration
Rockville MD 20857
I am writing to inform you that the Food and Drug Administration (FDA or the Agency) has not
yet resolved the issues raised in your citizen petition received on June 7, 2011, and submitted on
behalf of MSMB Capital Management LLC. Your petition requests that the Agency refrain from
approving radioactive sentinel lymph node detection agents without (1) accompanying data from
successful controlled trials of such agents compared against the standard of care for sentinel
lymph node detection, described in the petition as the combination of radioactive colloid and
blue dye, and (2) data from controlled trials which employ axillary dissection as the reference
truth standard.
FDA has been unable to reach a decision on your petition due to the need to address other
Agency priorities. This interim response is provided in accordance with FDA regulations on
citizen petitions (21 CFR 10.30(e)(2)). We will respond to your petition as soon as possible
given the numerous demands on the Agency's resources.
Sincerely,
I
.ajdvJ
A. Axelrad '
Associate Director for Policy
Center for Drug Evaluation and Research
F Dll f' o