Kane Biotech Inc V.KNE

News Release: Further information…

[MirrorWorldMan]

"The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request. MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE)."

[francoisl13]

The FDA site is updated every Monday (see lik below); CRDH 510k Approval database Based on KNE submitting their file in October and info provided by MirroWorldMan, I expect the coactiv+ approval to be published on Monday January 30th (earliest) or February 6th. GLTA

[RoyMax123]

someone posted this on CEO https://ceo.ca/kne?af99af499987  So I think we'll have to wait a bit more.

[RoyMax123]

BTW, He also posted that vids, listen at around 2Min https://www.paidpromotionalmessages.com/companies/news/1004091/kane-biotech-announces-distribution-agreement-for-coactiv-antimicrobial-hydrogel-1004091.htm

[francoisl13]

New video from Mr. Edwards talking about the upcoming catalysts for the company. Based on timing, I expect the 501k for coactiv+ to be approved next week (should know by Monday morning) by the FDA. This will triger a serie of good news from KNE. GLTA.

[MirrorWorldMan]

I read closely the details of 1year $5M credit facility from Pivot. The repayment terms are brutal, including an immediate repayment of $1M after an offering or equity investment, 15% interest rate, $1M Guarantor requirements and 2.5 M x .10 warrants. That is a desperate bridge financing and tremendous anticipation of revenue within one year. It is highly unlikely that Marc Edwards, averse to