Gerry ,I have had a look at this over past weeks and comment as...

Gerry ,
I have had a look at this over past weeks and comment as follows:

In drug development, where there is clinical need for a particular clinical condition treatment such as what SBP are attempting here, melanoma and mesothelioma, drug authorities MAY indicate during drug development discussions that based on clinical trial data available to the regulatory authorities, that a pIII clinical study MAY not required to gain a first approval for use. It all depends on the data generated and the quite high hurdle height that the regulatory authorities set. Jump the hurdle and all should be OK.
A recent case of this is Millennium (MLNM) in the US who gained US FDA approval based on 2 phase II studies for multiple myeloma (Blood cancer) for which it had been shown that the new treatment was significantly superior to the gold standard. However, there was a caveat in this case. MLNM had to do additional studies, basically phase III studies in previously untreated multiple myeloma patients.
So I do not take it as a given that SBP will escape having to do phase III studies at all. It is a case by case basis and I am sure that SBP will license out the drug at some stage if it proves to be effective as they claim with anecdotal evidence so they will no have to do the pIII studies themselves, the licensee will.
I have looked at the SBP web site and quite frankly, someone should complain about the quality of the info there, some of which is quite frankly BULLSHIT. They appear to be making a claim for 250 MM sales by 2006 - complete CRAP, they will not have SBP002 or any other drug in their pipeline approved by late 2005 imho to generate such sales in one year. Drug development is full of pitfalls and the unknown!
Other than that, SBP002 looks interesting.

I do not hold.


(Dr) SALTY