I've been waiting for an Ann since the March 8th to see what the outcome of the meeting with FDA was. It seemed to me that the meeting was in part about fast tracking the approval of RECCE® 327.
Based on the content in the March 8th Ann and reading through the FDA website i'm now more exited than offer about this drug. I think based on the fact it is already an award winning drug (see below quote from March 8 Ann) and the likely hood of this been fast tracked through FDA we're likely to get a sharp vertical climb as soon as the next Ann is made.
From March 8th Ann
"Recce’s lead compound RECCE® 327 was awarded Qualified Infectious Disease Product (QIDP) designation in late-2017, which provides a process to drug sponsors for expedited review and 10 years of market exclusivity post-approval for products that treat serious or life-threatening infections."
Below screen shot is from FDA website. Link is
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm
View attachment 1090489
I'm not a full bottle on the FDA processes and or timeline however they state "If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States". Surely life threatening superbugs more than qualify RECCE® 327 for fast tracking as they risk of not taking it is death.
Any thoughts?
Also has anyone got any thought on what the share price will be once this has been approved. Given "Recce has its eyes on the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) global initiative, which is offering a $1 billion reward for each new antibiotic approved, as well as increased R&D funding." I'm thinking $20-$50
Remember also that the RECCE® 327 drug is also going to be tested for cancer treatment, this was only put on hold as the company thought it better to focus on getting approval for superbug treatment and then double back to cancer treatment. If this is good for one only we will be dong ver well, if it works for both then surely the sky is the limit.
One last thought, this could also be used for treatment with animals. As a pet owner I know first hand just how much pet owner spend on the health and wellbeing of a fury family member.
Thanks and good luck to all.
(20min delay)