$BDTX Silevertinib safety is not the best, but it is not at "alarming level". If 150 mg (or lower) continue to deliver...CNS activity is definitive big plus. Will see how will potential partner react?
A Regeneron antibody was recommended by the @WHO for investigational use in response to the current Bundibugyo Ebola outbreak. Read more: https://t.co/NHHEW8Pgpb
@spontonic Serious TRAEs did not change, lower dose. They can not selectively negotiate with partner without public release of data, think partnering is on table.
@spontonic 200 mg has +60% G3 AE, so it is eliminated as option for p3. 100 will be lower, and 150 mg optional, if FDA agree. Think, they have a real shot! Partner would help(counting on it). Why did they broke ASCO embargo? Partner negotiation!
@AAMortazavi@JMaraganore From frontline science to approved drug roads are long, way too long. You know that! How long it took (by chance) to develop AI chip???
@BiotechObserver@DmitryKovalchuk@adamfeuerstein@CloisterRes If it is "new" indication that approved drug is targeting (in combination with unapproved candidate), than figuring out each single agent contribution is not that bad. However, anti-PD1 for melanoma is well characterized, and single agent was not necessary.
@BiotechObserver@DmitryKovalchuk@adamfeuerstein@CloisterRes Why they tested 4-fold dose level difference? It is more common sense failure (bad judgement) than simple "bad luck"! Why so large spread in PFSs, so chance that observed effect are for real are not with needed confidence??? Bad luck? Do not think so??? Bad FK/FD? Probably...