Ann: FDA Grants BTX 1801 QIDP Designation Status, page-48

I personally think BTX 1801 will be a company maker should this progress to market. ( Disclaimer : I said this about AD also )

The overall goal of the BTX 1801 program is for everypatient undergoing surgery to receive a treatment course of up to 5 days of BTX 1801 prior to surgery. There are over 300 million surgical procedures carried out globally each year.

Lets hope Vince has put this up on the top of his goals list for 2020 and beyond as 300 million patients times X Dollars = ( Insert Large Number )

Looking back at my AGM post I wrote this:

"I think they have something massive here (BTX 1801) and Dr Michael Thurn was clearly excited by the potential as stated by another AGM attendee."

As we know US investors stumped up $40 million for 190,476,191 shares at an offer price of A$0.21 just after their June 2019 announcement :
BTX 1801 kills superbugs without resistance: world-first study

At the least we have some good news flow ahead and great to have some positivity back on the thread GLTA


Just a recap from todays announcement :

Significant milestone for Botanix as BTX 1801 is the first cannabinoid-based program to receive the designation globally and represents a strong endorsement of Botanix’s data

The major incentive afforded to a product with QIDP status is an additional five years of regulatory exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA). This incentive significantly increases the commercial value of a successful product as it provides an extra 5 years of exclusivity, during which period generics cannot enter the market.

Botanix remains confident that as soon as travel requirements within Western Australia are eased, recruitment will resume, allowing the study to potentially be completed in 3Q CY2020.

Antibiotic resistance is a significant global challenge in the context of public health. The United Nations have estimated that the ongoing development of resistance to antibiotics could lead to 10 million deaths a year by 2050 and economic losses of US$100 trillion if new antibiotics are not found.

The increasing interest and availability of non-dilutive funding for therapeutics that treat bacterial infections, provides a unique opportunity for Botanix.