SGLT2 – Timing of IND acceptance? I admit I do not recall all previous board discussions (including those on wallstreet-online.de) in relation with the timing of the IND acceptance by the CFDA or, more precisely to the answer CFDA should allegedly provide within 60 days after filling. There were some debates as whether those 60 days should be computed on a calendar or on a business basis, some mentioning that the absence of answer within such period automatically leads to approval of the IND application.
As a reminder, reference is made to SBM PR –
Sirona Biochem Announces Receipt of $500,000 US Milestone Payment:
“The Company now awaits the China Food and Drug Administration (CFDA) approval of the IND filing, which will lead to a clinical trial of Sirona’s SGLT2 inhibitor for diabetes. The CFDA is required to respond to the submission no later than sixty days after filing. Filing took place December 27th, 2017. The acceptance of the IND application by the CFDA, will trigger another $500,000 USD milestone payment to Sirona Biochem.” (Emphasis added)
Note: The CFDA refers to clinical trial application (CTA), while the U.S. FDA uses the terminology investigational new drug (IND). Obviously, it cannot be contested that those 60 days (including all possible week-ends and holidays) have expired. However, I doubt such a “60 days” rule ever existed…
There were indeed
draft orders that have been released on 17 March and 11 May 2017, including the “Order 53”, but those were
proposed modifications presented to “public” comments. The following article might clarify the discussions about the calendar/business days and presents the new proposed mechanism, as compared to the current situation:
CFDA: Regulatory Developments on Drug Registration in China (20 September 2017)
CTA Approval
Order 53 proposes the adoption of a negative notification system for clinical trial approvals (CTA) in place of the existing positive approval system. Order 53 proposes a mechanism for an applicant to discuss with the CDE (Centre for Drug Evaluation, group within the CFDA in charge of technical review) before filing the CTA application. If the applicant does not receive negative comments within 60 business days after the CDE accepts the CTA application, the applicant can proceed with the clinical trial directly based on the protocol submitted without the need for approval.
Currently, CTA must be obtained before the clinical trial can start and the approval process has been lengthy (6-18 months). Order 53 proposes there to be deemed approval after 60 business days. (Emphasis added)
From the same author:
China FDA’s Pharmaceutical Regulations Ready for Public Comments (October 25 2017) I further investigated this subject but find no confirmation that the proposed modifications (including the “60 days rule”) have been formalized or implemented, or alternatively that “final” rules have been defined … before or after the submission date of the IND / CTA by Fosun (December 29, 2017).
This might explain why the IND / CTA acceptance by CFDA has been “
delayed”, as compared to the timing presented in the PR. If true, such interpretation raises additional question (and exclamation) marks on the management experience and credibility… while increasing the pressure on the company financial resources (my preliminary calculations – that should be verified – shows that the company might shortly run out of cash, possibly in May or June).
Obviously, I might be inaccurate in my assumptions and comments are welcome.
GLTA
Haiduk
For those interested and as a secondary debate (that hopefully will not affect SBM), the Chinese government now also intends to restructure its life sciences and healthcare agencies (CFDA will be dismantled or reformed?)… China’s New State Market Regulatory Administration: What to Know and What to Expect (April 3, 2018).
Additional background information might be find in the following articles:
After a makeover and hiring spree, China’s drug agency is romping and stomping on new reviews and approvals (March 28, 2018)
Bye CFDA: China’s drug regulator to take new shape in major government restructuring (Updated: April 26, 2018)
China Reorganizes Food and Drug, Healthcare Agencies in Significant Reform (March 27, 2018)