Komori
Shofu (7979) · RiskRestated

Delays in, or inability to obtain, approval or certification for new products

First written in FY2016. 1 of 2 entries say "Restated". Latest entry: FY2018.

2entries
3years
0from disclosures
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How it moved
ProgressHeldSoftenedWorseFirst statedFY2016 – FY20182016: 120162017: 020172018: 12018
Same theme, other companies
Uncertainty over regulatory compliance, approvals and launch delays for pharmaceuticals and regenerative medicine productsA theme 37 companies write about · 40 as a headwind · 0 as a tailwind

The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.

17 other companies' latest entry also says "Restated".

Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Showing 14 of the 37 companies compared. The sentences above are computed from all 37.
Full recordFilings, disclosures and news, newest first
  1. FY2018RestatedAnnual report

    「Even if the company is unable to launch a new product at the anticipated time, or has submitted an application for approval or certification, approval or certification may be delayed or may not be obtained for various reasons, including the application review process and GMP/QMS conformity assessments.」

    Reiterates the risk that delays in, or inability to obtain, regulatory approvals and certifications for new products could affect launch timing and profitability.
  2. FY2016First statedAnnual report

    「Even if the company is unable to launch a new product at the anticipated time, or has submitted an application for approval or certification, approval or certification may be delayed or may not be obtained for various reasons, including the application review process and GMP/QMS conformity assessments.」

    Discloses the risk that regulatory approvals and conformity assessments from research and development through commercialization could affect the timing of new-product launches and profitability.
Moved together

None of this company's other threads moved the same way in the same document twice or more.

When this could move next
Shofu's next results are scheduled for 2026-11-05. Read the earnings preview
News
No news is linked to this thread yet. When an article touches it, it will appear here by date.
Delays in, or inability to obtain, approval or certification for new products | SHOFU INC. (7979) | Komori