Entdoc,
Before we move on to more exotic combos, let's stay focused on 2nd line NSCLC and there the SOC is doxy. Let's walk before we run. This trial is directly, head to head with SOC. A first approval would be lucrative for PPHM and open up a lot of path ways, maybe even some that you envision.
For the record, if you do a deep dive into the anti-mitotic MOA of taxene based chemo you will find a discussion of the ancillary apoptotic effect on the cancerous cells. You will understand more than I do about tubular cell structure in the cancerous cell.
Also, it is my opinion that the chemo will do more to potentiate the effect of Bavi than to lessen it by causing greater exposure of the cell surface target PS.
It's not all that important that we get so finely granular. What is of more interest to me is that PPHM has hired the most successful regulatory authority in the country and this is the path he envisions for the quickest route to FDA approval. In my opinion, Garnick has selected well for the following reasons:
1. The disease is a deadly unmet need.
1a.The market is large enough and clearly implies a path toward
expanded indications that are multiples the size of the
initial market.
2. Garnick has "listened" very closely to the FDA in discussion
and this is the point of attack those discussions have
revealed that both fits PPHM technology and is of high
interest to the FDA.
IMO this is a smarter approach than selecting by intellect
alone.
3. Pre-clinical and early phase clinical work is highly
supportive.
4. Doxy is very deep into it's patented lifetime and is less
likely to be highly defended by Sanofi Aventis.
5. Sanofi -if they were smart and alive- would make an excellent
competitive bidder for this product.
6. IMO there is much we can learn from Garnick, inclusive of
medical politics, that is of interest for not only PPHM but
other bio tech investments. Remember, Garnick is the
regulatory father of drugs that do "many billions" of dollars
of business and most of them are not very good drugs.
All of the above is just my opinion except for the discussion about apoptosis which is in the literature on the chemo.
Best Regards,
RRdog
