I have re-read the announcement a number of times and had a chance to sleep on it, as I am sure we all have.... things that I have taken from it:
1/. If the words "from current data files" was at the end of this sentence in this paragraph then it would at the very least have assured investors that another trial is not necessary ? That concerns me !
Starpharma is currently evaluating the details of FDA’s advice but anticipates being able to address the issues raised through the generation of confirmatory clinical efficacy data.
2/. This comment .... Hmmm - so we obviously missed supplying them with some data or specifically something they asked for ? If this is the case Jackie should fall on her sword IMO as she oversaw the process ... we have ~$50m in the bank - hire an expert to ensure this submission addressed all areas.... what you have saved by doing it in house has just cost you many times more in revenue to name one ??? Credibility another ..... milestone payments another etc etc
“Clearly we are surprised and extremely disappointed with the FDA's requirement for confirmatory data in order to approve the NDA for VivaGel® BV considering the comprehensive nature of the data provided."
3/. This screams desperation of 'remember these' in an attempt to make us forget about what just happened ?
“Aside from VivaGel® BV, Starpharma will also continue to commercially exploit its deep portfolio of DEP® drugs, including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan and a range of other internal and partnered programs, including the novel oncology agent AZD0466, which is being developed under licence by AstraZeneca”.
4/. This I believe could be a positive, however it is a concern that at the beginning of the paragraph the dendrimer component is singled out and therefore it could be interpreted that the FDA did not think this about the product in its entirety ??
“Importantly for the dendrimer component of VivaGel® BV, which is the first of its kind to be reviewed by the FDA under an NDA, no issues were raised in relation to the safety, manufacturing or quality of the product.
5/. So in the following paragraph they are happy with the efficacy and the previous paragraph they are happy with the dendrimer component's safety, manufacturing, and quality....
In their advice, the FDA acknowledged the demonstrated efficacy benefits of VivaGel® BV although they have requested confirmatory data prior to approval.
Any wonder we are all confused ? Add to that we worked closely with the FDA and obtained a successful phase 3 trial outcome for Vivagel - go figure !
SPL management this just appalling and substantiates my no vote on the remuneration report. Instead of returning individual telephone calls IMO you should put out a unambigious announcement that investors can make informed decisions from ?
(20min delay)