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SEC Comment Letter for Enlivex Ltd. (ENLV) (CIK 0001596812) (ENLV) — Jul 24, 2014

Enlivex Ltd. (ENLV) (CIK 0001596812)
Date: July 24, 2014 · CIK: 0001596812 · Accession: 0000000000-14-037492

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
July 24, 2014
Author
/s/ Jeffrey P. Riedler
Form
UPLOAD
Company
Enlivex Ltd. (ENLV) (CIK 0001596812)

Letter

July 24 , 2014 Via E -mail Udi Gilboa Chief Financial Officer Bio Blast Pharma Ltd. 35 Ahad Ha'am St. Tel Aviv 6520206 Israel

Re: Bio Blast Pharma Ltd. Amendment No. 4 to Registration Statement on Form F -1 Filed July 15 , 2014 File No. 333 -193824

Dear Mr. Gilboa:

We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not bel ieve an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments.

Business, page 57

1. We note your statement throughout the registration statement that if the results of your ongoing Phase 2/3 clinical trial for Cabaletta are successful, you believe it could be a pivotal trial. Please expand your disclosure to state the basis for your belief. Spec ifically, disclose whether this belief resulted from discussions with the FDA.

Signatures, page II -5

2. Please amend your registration statement to include the signature of your principal accounting officer or controller.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and

Udi Gilboa Bio Blast Pharma Ltd. July 24, 2014 Page 2

all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commissi on from taking any action with respect to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and acc uracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to rev iew any amendment prior to the requested effective date of the registration statement.

Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 -3715 with any questions.

Sincerely,
/s/ Jeffrey P. Riedler

Show Raw Text
July 24 , 2014

Via E -mail
Udi Gilboa
Chief Financial Officer
Bio Blast Pharma Ltd.
35 Ahad Ha'am St.
Tel Aviv 6520206 Israel

Re: Bio Blast Pharma Ltd.
Amendment No. 4  to Registration Statement on
Form F -1
Filed July 15 , 2014
  File No. 333 -193824

Dear Mr. Gilboa:

We have reviewed your amended registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information.   If you do not believe our comments apply to your facts and
circumstances or do not bel ieve an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.

Business, page 57

1. We note your statement throughout the registration statement that  if the results of your
ongoing Phase 2/3 clinical trial for Cabaletta are successful, you believe it could be a
pivotal trial.  Please expand  your disclosure to state the basis for your belief.
Spec ifically, disclose whether this belief resulted from discussions with the FDA.

Signatures, page II -5

2. Please amend your registration statement to include the signature of your principal
accounting officer or controller.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and

Udi Gilboa
Bio Blast Pharma Ltd.
July 24, 2014
Page 2

 all applicable Securities Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commissi on from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and acc uracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration.  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of thei r respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time for us to rev iew any amendment prior to the requested effective date of the
registration statement.

Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me
at (202) 551 -3715 with any questions.

Sincerely,

 /s/ Jeffrey P. Riedler

Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
 Shy S. Baranov, Esq.
 Zysman, Aharoni, Gayer and
 Sullivan & Worcester LLP
 1633 Broadway
New York, NY 10019