Condoms down the drain..., page-27

Hi Perseng,
Just to be clear, I have absolutely no problem with your investment philosophy - SPL is absolutely still categorized as a high risk investment, and as such people need to make up their own minds about the fit for their portfolio. I personally run a very high risk portfolio compared to many recommendations I have read about the ideal portfolio, however I would not expect the vast majority of investors to have a similar risk appetite to myself. On the other hand, I also run a portfolio for a SMSF and almost all of the stocks I own in that portfolio are dividend paying stocks with a great history of increasing EPS and revenue, as well as increasing dividends. Different strokes for different folks so to speak

So as I said, I fully support your decision not to invest in SPL due to your assessment of the risk/reward for this stock.

However, that is where my support of your statements has to end. I find your comments regarding BV and the condoms both vague and rather uninformed. "Didnt we fail a trial a while back?" - shouldn't you know that precisely, and more importantly why before making your comments? That is exactly the kind of research I do before considering investing in a stock, as they say knowledge is power.

Yes SPL did fail a phase 2 trial, and the link to the announcement: http://www.asx.com.au/asxpdf/20121128/pdf/42bk7vdsslqt08.pdf

Unfortunately the Phase 3 trial for the CLINICAL CURE of BV was unsuccessful. Clinical cure is assessed at 2-3 weeks after the cessation of treatment.
HOWEVER, and this is important....

"While the primary endpoint in these studies was not met, these results do demonstrate efficacy of 1% SPL7013 Gel in treating BV, and are supportive of the hypothesis that recurrence of BV could be prevented by ongoing therapy (every second day), as is being investigated in the current phase 2 prevention of recurrence study, SPL7013-014." (Which as we know was successful: http://www.asx.com.au/asxpdf/20130403/pdf/42f19scnkdz5v0.pdf )

Furthermore: "Patients treated with VivaGel^® also reported rapid resolution of their symptoms (discharge and odour) within just 2-3 days of starting treatment, (FAST RELIEF) and this symptomatic relief was sustained in a significant proportion of women at the later (TOC) time point. This finding is another promising indicator for the performance of VivaGel^® in the prevention of recurrence indication as it shows that onset of the effect is rapid. This rapid onset of action in symptom control was matched by very encouraging patient feedback on acceptability (see below)."

And from the CEO:
"Dr Jackie Fairley, Starpharma Chief Executive Officer said: “We are surprised and disappointed in not meeting the phase 3 FDA endpoint for the treatment indication in these trials, given the phase 2 trial results; however, we are also greatly encouraged by the statistically significant efficacy and excellent symptomatic relief shown for VivaGel^® at the end of treatment in these studies and we do plan to fully explore the potential for regulatory filings based on these data. In addition we, and our expert clinical advisors, see the efficacy demonstrated with VivaGel^®, the excellent safety profile and patient feedback as very positive for the prevention indication,”
“With total global sales of ~$300-350M, the treatment market is significantly smaller and more competitive than the prevention of BV recurrence market. In that market – estimated to be at least 3 times larger – there are no approved products and VivaGel^®would be first in class. (FIRST IN CLASS... already plenty of OTC treatments Persing??) Partner interest in the prevention of recurrence indication continues to be very strong,” Dr Fairley added.
Due to its chronic nature and the high prevalence of recurrent BV (40-50% of BV sufferers), estimates by analysts, partners and Starpharma concur that the prevention of recurrence market is more than $1 billion (range 1-2 billion)."

Not to mention:
"The safety profile of VivaGel^® in these phase 3 trials was excellent, with very low rates of both genitourinary and non-genitourinary adverse events, and was consistent with administration of a locally applied, non-systemically absorbed agent. Importantly, there were very few instances of candidiasis reported in women taking VivaGel^®, with just 1.6% and 3.2% of women in 015 and 016, respectively, being diagnosed with the condition during the treatment and follow-up periods. This finding is in significant contrast to other BV treatments for which published candidiasis rates are around 10-20%. Following prolonged use of metronidazole, as many as 59% of women are reported to experience episodes of candidiasis, which result in further cost and inconvenience for women with BV. The safety profile of VivaGel^® in these studies is, again, highly encouraging in terms of the prevention indication."

My summary: While missing the primary endpoint of this trial, they did demonstrate a statistically significant cure rate, showed a much lower percentage of side effects than current treatments, and as I understand this announcement, as well as successive announcements, we have essentially already established that Vivagel is successful at symptomatic relief. However as I understand the way the FDA operates, if a trial fails its primary endpoint, it CANNOT then be submitted to claim a secondary endpoint. As such, in order to gain the NDA for the USA, a second Phase 3 trial (currently underway) is needed to demonstrate this to the FDA.

As such (and I apologise if I'm putting words in your mouth Antibotter!) I believe this is why antibotter has mentioned in other threads that the outcome of this trial is pretty much a foregone conclusion, and is very low risk of failure. Particularly since we already have marketing approval for this product in the EU, as well as likely approval in any country that also uses the EU Mark as a guideline. ( http://www.asx.com.au/asxpdf/20150924/pdf/431k3xq2m6t45f.pdf )

Please note I have added some comments and bold to quotes from announcements!