PolarityTE, Inc. (PTE) has seen a push of 7.64% in the premarket after the company announced updates on FDA Approval of IND for Pivotal Phase 3 Study of SkinTE. However, the last trading session closed at $0.7199 with a decrease of 1.06%.
3 Tiny Stocks Primed to Explode
The world's greatest investor — Warren Buffett — has a simple formula for making big money in the markets. He buys up valuable assets when they are very cheap. For stock market investors that means buying up cheap small cap stocks like these with huge upside potential.
We've set up an alert service to help smart investors take full advantage of the small cap stocks primed for big returns.
Click here for full details and to join for free
Sponsored
FDA Approval of IND for Pivotal Phase 3 Study
On 18th January 2022, PTE announced that SkinTE’s investigational new drug (IND) application for the treatment of persistent cutaneous ulcers has been authorized by the U.S. Food and Drug Administration (FDA). The FDA previously highlighted clinical hold points, which the Company properly addressed. With this approval, PTE can begin the first of two pivotal studies that will be required to support a biologics license application (BLA) for SkinTE to be approved for the treatment of persistent cutaneous ulcers.
Moreover, the approval of the IND is a major step forward for PTE and a credit to the whole team’s expertise and dedication. It’s worth noting that the decision to pursue a complex chronic cutaneous ulcer indication, which includes the most difficult and expensive wounds, is based on what the company has learned from the previous commercial experience as a 361 HCT/P and non-IND DFU and VLU RCTs, giving the team a lot of confidence as they prepare to start the first pivotal study soon.
Submission of Complete Response – What’s Next?
PTE reported on 20th December 2021 that it has filed a comprehensive response to the FDA’s clinical hold correspondence on its SkinTE IND application with a proposed indication for persistent cutaneous ulcers. Moreover, the Company presented a comprehensive response to the hold issues. If FDA determines that the Company’s response is complete, a decision from FDA should be conveyed to the Company within 30 days, subject to possible delays or other unanticipated circumstances, according to FDA’s customary policies and regulations.
Now what?
The company is immensely pleased with the whole team’s tremendous work in crafting the comprehensive response to the Agency. In terms of addressing the problems stated by the FDA, the company feels that the answer is thorough and convincing. Based on the entire answer, PTE cannot anticipate how the Agency will reply or if the IND will be approved, but they eagerly await the Agency’s response. In addition, the company remains absolutely focused and dedicated to getting approval of SkinTE’s IND application as quickly as possible so that they may begin the first pivotal trial, and they look forward to continuing to cooperate with the Agency as they progress SkinTE through the regulatory process.
