whilst not playing on the same field, both companies have received CRLs, one admitted that upfront and disclosed to the market and has actively been addressing the FDA’s request for several years and has made progress, hence the jump in price. They also have another accelerated pathway on offer for another product, so right at the cusp of FDA approval for two and possibly three if we look to later in 2025 or early 2026.
one company never mentioned any CRL for years and after one knockback, for a BV cream, gave up after several years of silence and shareholders kept in the dark. I’ve heard of BV creams on condoms, then nasal sprays… the oncology products only showed comparative effectiveness to products in the market, with safety benefits but no big pharmaceutical company cares. They want improvements in efficacy, not safety.
how much more time will Snail Paced Limited need, will it need to start up another round of clinical trials because the ones they’ve been running for over a decade have failed to partner.
CEO has jumped ship too. would she do that if there was genuine big pharma interest?
last time I looked, this company has jumped onto the Telix bandwagon and chasing radiotherapies, based on promising pre clinical data.
that sounds like back to step 1…
I may not have kept a close enough eye on things, so would appreciate your thoughts on where you think the good news is likely to come from?
exisiting phase 2 trials, or the new potential ones?
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