<<I believe we are watching a fundamental change in the company's history.>>
I have called this a 'defining moment' for the company, humble. The collaborative format for the clinical, and commerical development of FluInsure, will soon be set. The financial terms(up-front, milestone, and back-end revenues), as well as clinical trial cost sharing, will also be set. The financial market will have a much better idea concerning IDBE's financial position going forward. The company will also have the credibility of an industry partner(s) having validated its science. IDBE is currently talking to multiple parties, and options range from a traditional large pharma/biotech deal, to a deal with multiple parties(regional). The company believes it can obtain short, and medium milestone payments, as well as a high percentage of back-end revenues. To achive high back-end revenues the company will have to do more than just share in clinical trial costs, it will also have to share in manufacturing costs, such as for the Proteosomes. The company may also be involved in the commercial development of the vaccine, and distribute the vaccine in some territories.
Tony Holler also stated that he anticipates hearing back from the U.S. Government concerning pandemic flu, plague, and anthrax, within the next seven months. As we discussed before those agreements would ideally be signed before a FluInsure deal, providing a nice vote of confidence from both a legal party to the technology, and the institution where the technology was invented. In combination with a commercial deal on the Proteosomes, for Hepatitis B, for instance, Department of Defense deals could build important confidence in the technology ahead of a FluInsure deal.
The other value shaping events expected this year are FluMist approval, and clarification concerning any additional trials/studies the 'live' vaccine will require, as well as label issues. Since MEDI/Wyeth will only have six million doses to sell this year there could also be a quick sell-out, helping potentially validate nasal-flu vaccination commercially. Then there are the Phase II FluInsure trials which could help solve the one-dose issue, and increase the confidence concerning the two dose regimen, as well as remove the issue of thimerosol. It would be interesting to know how far off we were at one dose? Were any influenza symptoms mild, to virtually non-existant?
It seems like IDBE should hold off on a deal until later this year when some of the above events have occurred. The uncertainty however concerning the global political climate, and the need for a lead FluInsure deal to help build the platform for moving the rest of company forward off-sets this to some degree. Luckily FluMist approval is anticipated this month.
The mention of IDBE becoming a distributor in some territories is alarming, unless there is a merger with a major regional player. Of note, however, from what I've read, vaccines such as for flu will increasingly be distributed through more centralized distribution systems, as opposed to doctor's offices, for example. It may be more feasible for a small company to ship vaccine off to Wall Mart, in the future, who in turn can distribute the product to their stores for you. Pharmacies are also becoming more important players in this field, and this could increase with non-invasive delivery.
IDBE should keep the rights to distribute to centralized locations such as the above, in North America.
In this 'defining moment' for IDBE other Proteosome arrangements with industry, StreptAvax, and CPT must be considered.