Afternoon all.
Just thought I’d give you a quick wrap up on the AGM which I attended yesterday. I had a long chat with both Dr Elliot and Dr Caspari about the future of LCT prospects for LCT, details from what I can remember are as follows:
The 3 key goals for LCT by the end of the coming financial year is as follows:
1. Conclude clinical trials in Russia
2. Have some primary data available from the NZ trials
3. Advance FDA talks
On the FDA approval process:
LCT will be meeting with the FDA next month to advance talks with regards to conducting clinical trials in collaboration with the Barbara Davis Centre. Dr Caspari is confident that the FDA will approve the trials, especially now that LCT have had the full support of the NZ Government. Whilst the NZ approvals took longer than expected, Dr Caspari believes it’s a positive for LCT because the process was so thorough and rigorous.
On the NZ trials:
Screening will be taking place shortly for the 8 patients. Implants are expected to commence early in 2009. The first 4 patients will each be implanted with the middle dose (10000 IEQ) then the seconds group of patients will be implanted with the highest does (15000 IEQ). For safety reasons, patients are implanted one month apart from each other. So it will take 4 months for the first lot of patients to receive implants (10000 IEQ), then over the following 4 months the next lot will be implanted (15000 IEQ).
Obviously with the increase dose, LCT are expecting greater benefits (I.e further reduction in insulin required and better control of blood glucose)
Funding going forward:
At present LCT have $8M at hand which should see operations continue for a further 12 months, however realise they are going to have to raise additional funds at some stage. Existing shareholders (Navi Group I believe) have already expressed an interest in contributing further funds when required.
The Russians have quite a bit of interest in LCT from speaking with Dr Elliot. I believe that one of the directors / owners of the Navi Group is a Russian based in the US and has 2 children with type 1 diabetes. He went to school with the doctor conducting the clinical trials in Russia which is how LCT got started in Russia in the first place. So essentially these people have good reason for LCT to succeed and are also willing to fund it which is a positive in my opinion.
Further funding could also come through possible joint ventures with large pharmaceutical companies down the track, Dr Caspari has held senior positions in the some of these companies so I get the feeling he’s rather well connected.
There is a school of thought about a large pharma coming in and taking over LCT to put a stop to their product development. These large pharma’s make millions / billions out of providing products that are currently used to treat diabetes and some claim it’s not in the large pharma’s interest to find a cure for diabetes otherwise they’d lose their diabetes revenue. Dr Caspari is of the view that these large pharma’s know a cure is going to eventuate one day and he’s sure they’ll want to be in on the action sooner rather than later.
On the US Listing on the OTCQX:
Dr Caspari believes his role is to get out there and promote LCT and essentially sell the story to investors. He recently did an interview on a radio station with a reach of up to 5 million people and has many more investor meetings / presentations to attend upon his return to the US. He’s confident the exposure will result in increased traffic on the OTCQX (and a resulting SP increase). You can already see over the last 2 weeks the number of shares traded increased.
On the Pigs:
LCT is obviously aware that their competitive advantage and key to success is the germ-free pigs. They are in the process of building the new facility in NZ and I believe this now means they’ll have 4 sites to house the pigs (Also looking at a 5th). The main reason for this is to ensure that if infection occurs, it will be contained to one site so they’re very aware of risk management and taking all precautions to ensure their most valuable asset is safe.
Other bits and pieces:
A few questions were raised about the cost of the treatment. At this stage, no one at LCT was willing to put a price on it but did admit that initially it would be expensive, however over time this cost would decrease.
LCT are aiming at commercialising the product via the fastest possible route, to this means Russia is top of the list, followed by NZ and then hopefully the USA. In order for a product to obtain registration in the US by the FDA, clinical trial results must include between 25-40 implanted patients. So there are 10 in Russia, 8 in NZ and LCT are aiming to have the remaining done in the USA but are also looking at other countries presently.
I think I’ve about covered everything...
Have a good weekend.
Cheers
SW
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