"FDA approval I suspect would be an necessary element to a licensing agreement, this removes risk from a pharma point of view."
We just need to consider this in the context of what our CEO has been repeating over and over; the next steps for HerVaxx will be putting it in combination with existing therapies to give the best patient outcomes.
I do not see the company seeking an approval from Fda to go it alone with a registrational study or fast track approval for HerVax as a stand alone.
Therefore it would seem necessary to agree the partner / and select the existing drugs to combine with first, then seek any approval for fast track approval of those combinations. Without a partner agreed first, how could the combination approval be sought??
I recall a conversation last year indicating that 24 PFS events would be mandatory minimum before big pharma could run with it, and a fast track designation applied for.
So not long to go , IMHO
in Response to
@greystone the other day, a licensing deal with ongoing royalties would be my preferred outcome as i reckon the peak sales for HerVax could easily measure 5_10 billion Usd per annum within 5 years, across Gastric and Breast Her2 resulting in strong dividends for a long period. Many more vaccines could be funded "in house" using the upfront licensing fees and a portion of royalties not paid as dividends. See imugene.com website under the "pipeline" tab for the full list. There is still virtually zero value attached to this IP.
An outright sale of HerVax and/ or the whole BCell platform and mimitope platform
would probably result in these prize pipeline assets be given up way too cheaply at this stage. Look at it this way, for $2 a share 100% B cell buy out, Big Pharma could easily recoup that outlay from 1 or two years of revenues and be keeping the next 12 years all to themself.
or look at it this way, us$5 billion per annum in BCell peak sales, should see an upfront value of 4 times peak sales, as per recent acquisitions, therefore Us$20 billion. Which probably represents only a 25% market share for therapies that are proving to make the existing standard of care drugs obsolete and unethical.
(20min delay)