SEC Company Response from Aptorum Group Ltd (APM) (CIK 0001734005) (NIKI) — Nov 15, 2018
Aptorum Group Ltd (APM) (CIK 0001734005)
Date: Nov. 15, 2018 · CIK: 0001734005 · Accession: 0001213900-18-015877
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File numbers found in text: 333-227198
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CORRESP
1
filename1.htm
APTORUM GROUP LIMITED
17th
Floor, Guangdong Investment Tower
148
Connaught Road Central
Hong
Kong
November 15, 2018
VIA
EDGAR
Keira
Nakada
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Consumer Products
100
F Street, N.E.
Mail
Stop 4631
Washington,
DC 20549
Re:
Aptorum
Group Limited
Amendment
No. 1 to Registration Statement on Form F-1
Filed
October 5, 2018
File
No. 333-227198
Dear
Ms. Nakada:
Aptorum
Group Limited (the “Company,” “Aptorum,” “we,” “us” or “our”)
hereby transmits its response to the letter received from the staff (the “Staff”) of the Securities and Exchange Commission
(the “Commission”), dated October 11, 2018 regarding our Registration Statement on Form F-1 (the “Registration
Statement”) previously submitted on September 5, 2018 and amended on October 5, 2018 (the “Registration Statement”).
For ease of reference, we have repeated the Commission’s comments in this response and numbered them accordingly. A second
amended F-1 submitted publicly accompanying this Response Letter is referred to as Form F-1.
Please
note that new language we are including in Form F-1 pursuant to your comments, is indicated in this letter in bold, italicized
font; any deletions from the initial Registration Statement are indicated in this letter as strikethrough
font.
Our
Business
Statistical
Significance, page 82
1. We
note your response to comment 4 and your disclosure that you do not intend to use for
any regulatory submission the standard of statistical testing that you have employed
to compare different treatment groups. Please revise your disclosure to explain how standards
for statistical significance relate to the U.S. Food and Drug Administration’s
evidentiary standards of efficacy.
Response:
In response to the Staff’s comment, we revised our disclosure as follows:
“Statistical
Significance
The
term statistical significance is to define the probability that a measured difference between two groups (e.g. two treatment groups,
treatment versus control groups) is the result of a real difference in the tested variations and not the result of chance. It
means that the result of a test does not appear randomly or by chance, but because of a specific change that is tested, so it
can be attributed to a specific cause.
The
confidence level indicates to what percentage the test results will not commit a type 1 error, the false positive. A false positive
occurs when a change in the result is due to randomness (or other noise) and not the change in variations. At a 95% confidence
level (p = 0.05), there is a 5% chance that the test results are due to a type 1 error. 95% has become the standard and usually
be the minimum confidence level for the tests. To make the test more stringent, a 99% confidence level (p = 0.01) is also commonly
employed, which means that there is a 5 1% chance that the test results are due to a type 1 error.
In
other words, a p value represents the confidence level. For example, if the p-value for a test is < 0.05, it means that there
is less than 5% chance the difference between two groups is due to random error or by chance. If the p-value is < 0.01, it
means that there is less than 1% chance the difference between two groups is due to random error or by chance.
We
employed statistical testing to compare different treatment groups in animal studies simply for proof of concept and to aid internal
decision making for further development. We do not intend to use this standard for any regulatory submission. The US FDA
or other regulatory agencies may not necessarily employ the same statistical standard to assess the efficacy in clinical trials,
the results of which would be submitted for regulatory approval. Although a p-value of 0.05 has become the standard,
Tthe US FDA or other regulatory agencies may also individualize their efficacy standard for different clinical
programs based on the indications, the purpose of a clinical trial, among others.”
We
thank the Staff for your review of the foregoing. If you have further comments, we ask that you forward them by electronic mail
to our counsel, Louis Taubman at ltaubman@htflawyers.com or by telephone at (917) 512-0827.
/s/ Ian
Huen
Ian
Huen
CEO
cc:
Louis Taubman
Hunter
Taubman Fischer & Li LLC