We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon
Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
People don't learn. There was a message after we added another buck on Wednesday about how that was good. And you awakened the "Gris Gris". Shame shame shame! ;)
I try to not get excited about moves either up or down at this point, we're waiting for
1> resubmission 2> approval
Pretty much everything else is noise.
Just to contradict myself though, I do find it interesting that IMMU didn't slack off after the CRL, they continued full steam ahead. I'm sure they may have trimmed back on some new expenditures, and maybe left some positions open that they would have filled if there were no CRL. And sure, good news for UC will be welcome (and any other study results of course). It's just that until the CRL issues are fixed (and the FDA agrees), I'm not going to get giddy...
Imagine the CRL if Dr. G. were still in charge and we had only had a few months operating expenses in the bank.....
On its face, they are certainly making a big deal out of their data as a significant event for investors. Would it be too much to conclude that the data is very good and the numbers large enough to support filing for BTD?
If DrG was still in charge, we'd be out of money. Someone else would own most of 132, but he'd have sold that stake for much less than Behzad got from Royalty. The share price would be in single digits and he and MsS would still have their beaks stuck deep in the withered carcass. I need to go bleach my imagination thank you
Doc, I have to wonder if the company didn't already file for BTD some time ago, and I think that Mr. Ranch once posited that during my period of being banished and wandering in the SI wilderness as The Ronin. MAF
>>Would it be too much to conclude that the data is very good and the numbers large enough to support filing for BTD?<<
No, not too much to ask but I'm hoping IMMU has learned to under-promise and over-deliver. For your reference, when IMMU received BTD for IMMU-132 in the mTNBC indication, there were 60 patients enrolled in that ph. II. That was the first part of the Simon Two-Stage Analysis. The FDA next asked for another 40, or so, patients which got us to a bit over 100, on which the BLA was based. It is also worthy of note that the BTD for those 60 patients (58 evaluable) had a data cutoff of November 10, 2015. Clearly, BTD is but one leg of the run to approval. That said, we do have a lot of data on about 1,000 patients for 132 at this point, so I want to believe things will move along at a quicker pace. What's holding things up on the BTD front, I imagine, is the more recently ongoing recruitment of post-CPI patients in the UTC indication.