biota will enjoy all the spoils-the australian, page-30

My head is spinning out on where this thread has come from and where it has got to.

The $231m is in the vicinity of what it is going to cost to complete Phase III trials for ROW. If the amount was going to be much more or less, it is likely that the BARDA grant would have reflected this.

If we are arguing on the % chance of success of getting LANI to market, I think it is best to say that there is an element of risk in this game, with whatever product (be it Panadol) and with whichever company (be it Johnson & Johnson) and add to this the normal FDA delays, which are ridiculous at the moment.

Now, we can best deduce that we have a pretty fair chance of getting LANI to market. We know that Biota management have traditionally not had good business brains, but scientifically, they really know their stuff. I believe the scientific brains in this business have the expertise and experience to take a drug through Phase III trials. Furthermore, if they are running a trial underwritten by BARDA, I am sure they will be well supported by BARDA resources to ensure that the correct steps are taken.

[As a side note, Biocryst totally ballsed up their trials, and BARDA actually threw more money in to help them reset the parameters of the trials. I'm not suggesting Biota would screw up their trials, but this is just a background example on a company with far less credibility and the helping hand they have received]

As for FDA delays, they are a real problem at the moment, but we know that in the case of Influenza vaccines and antivirals, the FDA has a totally different attitude - I don't believe that the FDA will create any unnecessary roadblocks.

And finally, the wildcard - unfortunately there is a good chance of more pandemics in the foreseeable future. This elevates the opportunity for LANI (once it is well into its trials) being given temporary emergency approval status well before the 5yr time frame to market.

Once the Genie is out of the bottle, look out!