From the postings on this site, most of you seem unaware of the challenges which SPL face in gaining FDA approval for Vivagel, both as a cure and a prevention.
The FDA submissions themselves are enormous, the current page count of the SPL BV submission is over 25,000 pages. It contains:
- A complete history of the development: research, pre-clinical and clinical trials in a form prescribed by FDA,
- Detailed data of the all Phase trials,
- Comprehensive details of the raw material used and where these are sourced,
- Comprehensive details of the manufacturer of the product and any packaging,
- Evidence of FDA approved audits of all parts of the manufacturing chain.
The arrangement which SPL negotiated with FDA, incorporating pre-agreement of the trial design allowed SPL to obtain European approval even though the FDA agreed endpoint of the first Phase 3 trial had not been reached. European authorities accepted SPL's recommended endpoint time over that prescribed by the FDA (which was subsequently revised by the FDA).
The FDA submission is well advanced and under the preferential arrangement now in place can be submitted in parts. It is not a process which involves a one time submission of 25,000 pages with a wait for a decision.
The FDA will determine whether the treatment will be licensed for over the counter or prescription. It may start as one and subsequently move to the other. It should also be noted that the pricing algorithms tend to be channel specific so a prescription drug will tend to have lower volumes and higher costs than a OTC drug with higher volumes and lower costs. The end result to SPL may not be much different.
Now only a handful of Australian companies have ever managed a successful submission of a new drug to the FDA. The agreed status of those submissions as Fast track and QIDP are indicative of the achievements of the company so far in their negotiations with the FDA.
It is happening! But it is a huge task!
Why have the AZ payments not been received? Simple! An AZ supplier was late delivering a key component in preparation for the clinical trials. The relationship with AZ is solid the SPL input has been very well received but the milestone event was delayed, hence the payment.
