They have been working hard. I believe all that w
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Combo—awaiting FDA decision on 525mg vs 700mg safety data, BLA should be done either way within 3 months
Mono—awaiting FDA meeting
TNBC—finally we should get the first injection within a couple of weeks.
I posted this a while back, I still believe it has been the main delay.
Quote:
Yes, the ccr5 groundwork was already laid with HIV. Even though they have the two leaders of their field with ccr5 and ctc (Pestell and Cristofanill respectively), they definitely underestimated the time it took to set up the ccr5 biomarker with metastatic cancer. Though the importance of this ground work will probably not be realized until they move from tnbc to MOA with all ccr5+ metastatic cancers with probably very little modifications needed.
GvHD—injection should start soon
Nash—animal study results a month away
ProstaGene™ Prognostic Prostate Cancer Test—awaiting FDA’s answer on meeting request
Colon Cancer Phase 2 IND—should be out soon
Partnerships—it seems they are finalizing at least two, maybe three: company in China, Company with Prognostic Test, Samsung, also NP said BP is back at the table
Investor Awareness: I believe their new IR company is working on this. We are not there yet, but I’m like the improvement curve so far over the last IR.