The good news today is the company has filed the required 10Q SEC quarterly audited financial statement and the FDA requirement.https://investorshub.advfn.com/stock-market/U...-13-or-15d
"On March 6, 2026, the FDA communicated their approval of the external audit firm that we had proposed on February 16 to conduct a GCP Audit of our procedures, process and personnel. This audit is expected to be completed by the end of October 2026. On July 6, 2026, we approved a proposal by NAMSA, a global CRO specializing in medical devices, to serve as Sponsor in our planned clinical study. We are currently working with NAMSA to complete their diligence and assist in developing an Investigational Device Exemption (IDE) application that NAMSA will submit to the FDA."
The timing to resolve the FDA Warning Letter is uncertain and we may not proceed with a Premarket Approval application to the FDA until its resolution. However, following consultation with the FDA, NAMSA will serve as substitute Sponsor of a CelluSTAT study, with UHP having an exclusive Rights to Reference to the study data for inclusion in a future PMA application. This plan would allow the study to be conducted concurrently with our ongoing efforts to resolve the Warning Letter, including the above mentioned GCP Audit.
Progress if this is the FDA matter of a third party independent review of internal controls as well which reports will be completed by October 2026.
Hopefully the submission will be completed and accepted by FDA.
$5-$10+
"On March 6, 2026, the FDA communicated their approval of the external audit firm that we had proposed on February 16 to conduct a GCP Audit of our procedures, process and personnel. This audit is expected to be completed by the end of October 2026. On July 6, 2026, we approved a proposal by NAMSA, a global CRO specializing in medical devices, to serve as Sponsor in our planned clinical study. We are currently working with NAMSA to complete their diligence and assist in developing an Investigational Device Exemption (IDE) application that NAMSA will submit to the FDA."
The timing to resolve the FDA Warning Letter is uncertain and we may not proceed with a Premarket Approval application to the FDA until its resolution. However, following consultation with the FDA, NAMSA will serve as substitute Sponsor of a CelluSTAT study, with UHP having an exclusive Rights to Reference to the study data for inclusion in a future PMA application. This plan would allow the study to be conducted concurrently with our ongoing efforts to resolve the Warning Letter, including the above mentioned GCP Audit.
Progress if this is the FDA matter of a third party independent review of internal controls as well which reports will be completed by October 2026.
Hopefully the submission will be completed and accepted by FDA.
$5-$10+
