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“The real driver(s) of the aytpical golodirsen CRL will continue to be a debate based on limited public disclosure of the granularity of facts, but the macro take home is clear in our minds—there is a regulatory “raising of the bar,” the analysts wrote. This could spell bad news for Sarepta’s other programs, namely its microdystrophin gene therapy that the Evercore ISI analysts consider the “major valuation driver of [Sarepta] stock.” ... Sarepta’s recent communication strategy “on many elements has been atypical relative to traditional biotech company communication—yesterday’s press release [about golodirsen] is obviously just the most recent example,” the analysts wrote.
I'm not saying this reads through directly to IMMU's current situation, but there are some parallels to the situation with Sac. G. and a raising of the approval bar wouldn't generally be considered good news for IMMU. I still have high hopes for the ADC in general, but I'm leaning toward a later approval date than expected given this.
I know I state the obvious. As long as there have been markets, there have been swindlers. For the 1,000s of years we have markets, the brightest people in the industry have been snookered. There are are some good crooks out there, now, and very sharp people getting it. Down a dollar today, someone made some bucks. I have a lot of this stock, I believe in the science. But I have said before the science is passing IMMU. I am most distressed by the friends and patients, I have lost to the greed and incompetence of our system. Is time to rethink how we do medicine In the US
We are very surprised to have received the complete response letter this afternoon,” Sarepta CEO Dough Ingram said in a statement released by the company. “Over the entire course of its review, the Agency did not raise any issues suggesting the non-approvability of golodirsen, including the issues that formed the basis of the complete response letter.”
I thought the share price would resolve itself in that triangular channel in October on BLA resubmission. Maybe that DS-1062 data release will materially impact the share price today though. We'll find out soon.