sdrawkcabman twitter comments 09/11/2018


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a hui hou!
George Budwell’s flagrant non-sequitur, Part 1 of 2.

George Budwell’s misguided article is predicated on a flagrant non-sequitur. He says a continuation
decision will not be a “major market-moving event” b/c the first phase of Imerge was not designed for
filing, Huh?

What is the connection between the continuation decision and Imerge’s first phase not being designed
for filing? Totally anomalous. Wherein does the value of the continuation reside? In Imerge’s first
phase? What? Why? HUH? The continuation decision is about Imet’s ENTIRE program

To put it in high relief, let’s say the continuation decision was negative; would THAT be a “major
market-moving event,” independent of any regulatory filing? Of course it would. That’s b/c the
continuation decision is not, and was never, about any regulatory filing A POSITIVE
CONTINUATION DECISION MEANS THE PARTNERSIHP IS MOVING FORWARD, instead of
being returned to Geron; it means the cost structure is 20/80; it means there are milestone payments to
put on the books; it means the program is being expanded,

What does a LegulatogLfiling have to do with the The continuation decision is
not predicated on a regulatory filing; why would you associate the two in the first place? It seems the
design of Imet’s program is over Mr. Budwell’s head‘ He also fails to understand that they must
continue in order to begin the secondphasehfilmerge, and also an AMLtriaKand we now know they
ARE doing something with AML, don’t we). Is that not a substantive development in the program,
separate from any regulatory filing?

What a thinly drawn and tortured connection to make, Mr. Budwell, and a very ponderous article full of
“huh”s

George Budwell’s flagrant non-sequitur. Part 2 of 2.
Also, these are some of my notes from the May conference call:

And we can be extremely confident that Imerge will be a pivotal b/c of the double—blind, placebo
protocol, but also b/c of Olivia’s response to a question about the hypothetical case that the
continuation decision was negative. Regarding the shelf offering, Olivia said, “Since the data
from [Imerge] would have to be used to support a potential regulatory approval...” Imerge is a
pivotal trial.

Again, in the hypothetical case of a negative continuation decision, Dr. S responded, “Well, first
and foremost, assuming the data from Imerge supports moving into P3, our priority would be to
get the P3 of Imerge up and running as soon as possible. We believe that MDS presents a
straight forward path to potential regulatory approval b/c the trial’s already been designed
including the endpoints, and as part of the P2 portion of the study most of the clinical sites have
already been established and are familiar w/the clinical protocol.”

Nowhere did they ever create the expectation that there would be a filing based on the first phase of
Imerge. Mr. Budwell seems to have synthesized that idea out of thin air, all by himself. Yes, the P3
phase of Imerge could unfold on the time—scale Mr. Budwell gives; but he also ignores any discussion of
a rolling submission as N] had done for Darzalex in 2015. After all, they have unprescedented results
in both MF and MDS, and there was an expansion group in Imerge whose data will be quite mature
within the first year, post-continuation.

Mr. Budwell’s article was so thinly drawn, I don’t understand why anyone would print something so
undeveloped. Was it to garner viewership during a time of peak interest, perhaps? Financial
journalists...

I have to say, the analysts and financial journalists covering Imet seem to be largely and woefully
ignorant of the scientific import. It’s disconcerting to see so many of them write so voluminously, and
yet say so little. It’s almost like they just want people to click on their articles.
 




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