Replies to post #29 on Gamida Cell Ltd (GMDAQ)

[Spideyboy]

Indeed it does,

With enrollment completed on Jan 2nd, and a study that lasts 42 days, finishing about mid-Feb, then I think can expect data in April. However interesting to note that the Gamida guidance simply stated 1H2020, perhaps that just as they're not sure it will be end March or early April and hence mentioning a specific quarter is too difficult.

Right now I really like GDA-201, and if we can pool the understanding of the performance with that if FATE's near identical product then will be much clearer to see the potential.

They plan to start a Phase I/II study in 2021.

Cash looks clearly enough to get it to FDA submission, and with what I believe is the 6 month review time-frame from Breakthrough Designation, could even get them almost to approval. But by end-2020 they will need a boost, specifically if they plan that Phase I/II for GDA-201.

Looking again at FATE's product, FT516 is in Phase I but with only probably 2 patients dosed, compared to GDA-201's 22 dosed and many with results, so hopefully that should put Gamida a little bit ahead of FATE, though if Gamida wants to be first to market they will want to hurry this up.

In FATE's latest nothing PR which again sent their stock soaring (sigh :), I note that they seem to specifically mention about a "novel variant of CD-16" being expressed on their NK cells. CD-16 naturally occurs on NK cells anyways so I'm not exactly clear on how much of a variant they can make. As even a small variation can lead to a non-functional protein. To really come up with some sort of greater affinity variant as they claim would seem a lot of extra research with little added-value I would think. Seems like a bit of added pump information to me, and it seemed to do the trick! Hope I'm not being biased here though :)

Hoping the market gets more excited about omidubicel data/approval than they were about Talicia approval though. I mean amidubicel does have a bunch of buzz words around it, Breakthrough Designation, Orphan Drug Designation, First allogeneic Stem Cell transplant and all that, and zero-competition achieving their results.

I think you'll do well with your largest holding. I'm on tenterhooks for PLX data. Hoping for astounding data vs current ERTs. I find almost no reason why that data shouldn't be great. The last webcast with Dr Warnock was very nice with the 12 month data in the first 16 patients.