Ann: SPONTAN achieves positive clinical study results, page-185

So many missing the point that vardenafil which is the drug Spontan will be delivering via its nasal spray, has already been approved by the FDA. That means the drug has been tested extensively and proven to work. Link to FDA approval https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm

LTR’s clinical study therefore aimed to show the TMax (time to max) peak concentration in the blood of its delivery method. The study confirmed that Spontan through its innovative nasal technology is proven to work at a lower dose over oral ingestion, which means Spontan has lower/minimal side effects. Most importantly, Spontan achieved rapid absorption in the blood stream at an average of just 12 mins (and as quickly as 9 mins) compared to 56 mins when the drug was taken orally. Vardenafil itself has been proven to improve erections in 92% of patients according to some studies and LTR Pharma has a solution that gets the drug into blood stream rapidly, so debate about healthy males age grp of testing grp etc, is just not relevant to any argument. Vardenafil works and is FDA approved just in case you missed it.

LTP will file for a fast track US NDA filing in the immediate future given the bioequivalence trial, equivalent to a PHASE III for a new drug…that’s massive in itself and has been missed by many. Biotechs spend years and enormous amounts of money just to get to stage III, with many not even making it.

Spontan will also be registered for Special Access Scheme with the TGA given vardenafil is currently registered and is simply being repurposed via the delivery method. This means the nasal spray could available in Australia in the coming months. This will add weight to the FDA and other filings.

Trading activity has been very interesting in the last few sessions and post Lee’s visit to the US where I’m sure he has the attention of all his peers and big pharma. Exciting times ahead!

DYOR