It's also interesting that you call TruScreen the main game. It is for now, but tracing back to the big spin put on by the company last year, it appeared as if they saw CerviScreen as being as big as TruScreen a number of years down the track. I don't know if that situation has changed with them outsourcing the test component or not ... hopefully it will just speed it up and get them back on track for getting it out there quickly enough to be a market leader.
I've had a few more thoughts on CerviScreen as well, and would mainly like to point out some things said about it in the past two 'General Shareholder Update's:-
August 2008: =========== >>>> CerviScreen – HPV Self Sampling
Activity on CerviScreen has moved forward in a number of areas.
We are negotiating to establish a preferential partnership with third parties for the supply of pathology services to complete clinical trials for CE and TGA registration. We expect these negotiations to be completed shortly. These trials are required to establish our claims for CerviScreen to be used by women for self-sampling and avoid an unnecessary and unpleasant pelvic examination for primary screening for HPV. Our trials are expected to be completed in the near term.
Our preferred pathology service partner has expressed interest in supporting CerviScreen in its market launch post CE accreditation in Australia, NZ, South East Asia and Europe. We have also received strong interest from our Chinese distributor for CerviScreen entry into that country, and from senior medical practitioners in the US.
Both China and the US have independent product registration systems to be passed prior to market entry.
We are currently in discussions with an Australian distributor and anticipate the self-collection device will be available for general swab use by medical practitioners later this year. Forensic and veterinary services will also be targeted for use of the general swab <<<<
April 2008: =========== >>>> CerviScreen
We had expected to commence sales of CerviScreen (our HPV/DNA self-sampling collection test) prior to 2Q08, however our prime focus has been the commercialization of TruScreen.
We have however made progress on a number of fronts: - Our sampling device is CE (Europe) and TGA (Australia) approved. - Our FDA (USA) submission is being prepared. - Validation tests have confirmed the diagnostic ability of our test. - Refined our marketing strategy. <<<<
From these, I'd like to make the following points / observations / speculations:-
1. in April the headline was 'CerviScreen'; in August they added the '– HPV Self Sampling' postfix to it. This was a clue as to the new direction they have decided to take (i.e. the Self-sampler being the product, leaving the test component to the Genera test)
2. in April they declared that their "sampling device is CE (Europe) and TGA (Australia) approved". In August they were "negotiating to establish a preferential partnership with third parties for the supply of pathology services to complete clinical trials for CE and TGA registration." and expected the "negotiations to be completed shortly". Therefore, as at 3 weeks ago they were still looking at proceeding with their own test. My guess is that Gribbles convinced them that the Genera test, that they had already worked with and done clinical trials on, was the way to go forward.
3. The US: the market for DNA sampling in the US is huge, and I believe it is another announcement that PLT might make in the near future, given that Genera are going to America via Sonic Healthcare ... I would be surprised if PLT don't also team up with them. In August they mentioned that "We have also received strong interest from our Chinese distributor for CerviScreen entry into that country, and from senior medical practitioners in the US.". Note that the work done with Gribbles is going to allow fast-tracking of the test's use in the US, allowing it's use prior to the usual FDA approval process, and presumably PLT's test will be ready to roll as soon as Genera's is cleared (pre-FDA). Go back to the various posts on the subject from Deca (on this forum and GBI from April) for details on how this will work. Note also that in April they stated that "Our FDA (USA) submission is being prepared" ... my guess is that the sampler will be ready to roll in the US by the time Genera's is, which I think is expected to be in the second half of 2009 (calendar year).
4. as per the August quote from #3 above, they stressed their Chinese distributor as expressing a strong interest. I'm not aware of near-future plans from Genera regarding China (from memory; I might be wrong, I haven't revisited their story lately). A bit of speculation here: I'm wondering if that's where the existing test fits in? If there are no current plans for Genera in China, might PLT be considering getting their test registered, with the help of their distributor? There was no mention of the test being discarded in today's announcement, just that they were using Genera's in Australasia ... hmmm.
5. My guess that "GenSwab" stood for "Genetics Swab" might have been wrong ... note that the August release refers to "the general swab".
With all of this speculation, I feel it is probably time to give Ben a call (as we have finally been invited to do again, as per the release) to clear some of it up and get a better handle of the scope of this deal and their (other?) plans for the future. Possibly next week (unless someone else makes the call and is allowed to publish a summary).
Anyhow, whilst some other thoughts swirl around in this cluttered brain of mine, I'd better press the 'Post Message' button and get on with work.
Cheers.
PLT Price at posting:
11.0¢ Sentiment: Hold Disclosure: Held
(20min delay)