I find your post interesting and sensible. But as of this time, defined as that of pre-trial results, I surprisingly can't agree that it is, "...completely unrealistic" to expect success, even though some CEO's have reached this point without assistance from Big Pharmas. In fact, comparing HGEN and CYDY, as you did, I actually think HGEN has been held back more than CYDY at this point, in terms of share price appreciation, anyway.
So, I'm not too concerned that Leo has yet to obtain a Big Pharma partnership to help influence FDA approval. The golden egg for IPIX will be the safety and efficacy of Brilacidin. In the same way, the only real influence on the FDA for CYDY will be the safety and efficacy of leronlimab.
Where HGEN has benefitted from participating in the NIH Activ5/BET trial with Gilead, is that the company now has access to the resources of CRADA and BARDA. I think this has been invaluable in planning the commercialization and distribution of the product, once they have an EUA. It also gives the company access to tap into manufacturing capacity that has been reserved by BARDA. This could be critical in terms of producing enough product to meet national reserve target levels. HGEN's management team has done a tremendous amount of work in developing their business plan for once lenzilumab has been approved. I don't see that degree of progress in that regard from IPIX, CYDY, or RLFTF.
None of those companies, nor HGEN, has yet announced a tender offer or some type of partnership with Big Pharma. In fact, CAR-T may be HGEN's biggest revenue producer. They are in another clinical trial with GILD to treat that indication. But, they have refused to sign an exclusivity agreement with GILD for the use of lenz, despite the fact that GILD is funding most of the costs of that trial.
I would hate to see any of these companies sell out to Big Pharma. But I think HGEN is best positioned to maintain independence going forward. Once the trials are complete, it may be necessary to see some buy-outs or mergers, but to this point, I think the companies have acted prudently, even if it involved toxic lending. Those lenders can be paid off quickly once the products are approved and revenue streams begin.
