SEC Company Response from Enlivex Ltd. (ENLV) (CIK 0001596812) (ENLV) — Jul 25, 2014
Enlivex Ltd. (ENLV) (CIK 0001596812)
Date: July 25, 2014 · CIK: 0001596812 · Accession: 0001144204-14-044910
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-193824
Letter
Via EDGAR Securities and Exchange Commission Division of Corporation Finance 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. Riedler:
The purpose of this letter is to respond to your letter of July 24, 2014 regarding the above-referenced amended registration statement. For your convenience, your comments appear in italics, followed by our responses. We are concurrently filing via EDGAR Amendment No. 5 to the Form F-1 (“Amendment No. 5”). Page references in our response are to Amendment No. 5.
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. Specifically, disclose whether this belief resulted from discussions with the FDA.
We have revised our disclosure on pages 1, 3, 51, 57, 58 and 60 of Amendment No. 5 to add the following: “We believe, based on discussions with the FDA, that if the Phase 2/3 trial shows positive results, the data could be considered pivotal data, considering, among other things, the applicable FDA guidance for the industry called “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.”
Signatures, page II-5
2. Please amend your registration statement to include the signature of your principal accounting officer or controller.
We have revised page II-5 of Amendment No. 5 to indicate that Udi Gilboa is our Principal Financial Officer and Principal Accounting Officer.
* * *
We appreciate your comments and welcome the opportunity to discuss with you our responses provided above. Please call our attorney, Shy Baranov (617) 338-2932 of Zysman, Aharoni, Gayer and Sullivan & Worcester LLP, if you have any questions or require additional information.
Sincerely,
Bio Blast Pharma Ltd.
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CORRESP
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BIO BLAST PHARMA LTD.
37 Dereh Menachem Begin St., 15th
Floor
Tel Aviv 6522042 Israel
July 25, 2014
Via EDGAR
Jeffrey P. Riedler, Assistant Director
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
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. Riedler:
The purpose of this letter is to respond to your letter of July
24, 2014 regarding the above-referenced amended registration statement. For your convenience, your comments appear in italics,
followed by our responses. We are concurrently filing via EDGAR Amendment No. 5 to the Form F-1 (“Amendment No. 5”).
Page references in our response are to Amendment No. 5.
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. Specifically, disclose whether this belief resulted from discussions
with the FDA.
We have revised our disclosure on pages 1, 3, 51, 57, 58 and 60
of Amendment No. 5 to add the following: “We believe, based on discussions with the FDA, that if the Phase 2/3 trial shows
positive results, the data could be considered pivotal data, considering, among other things, the applicable FDA guidance for the industry called
“Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.”
Signatures, page II-5
2. Please amend your registration statement to include the
signature of your principal accounting officer or controller.
We have revised page II-5 of Amendment No. 5 to indicate that
Udi Gilboa is our Principal Financial Officer and Principal Accounting Officer.
1
* * *
We appreciate your comments and welcome
the opportunity to discuss with you our responses provided above. Please call our attorney, Shy Baranov (617) 338-2932 of Zysman,
Aharoni, Gayer and Sullivan & Worcester LLP, if you have any questions or require additional information.
Sincerely,
Bio Blast Pharma Ltd.
By: /s/ Udi Gilboa
Name: Udi Gilboa
Title: Chief Financial Officer
cc, with a marked copy of Amendment No. 5:
Christina De Rosa
Shy Baranov, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
Oded Har-Even, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
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