New discussion topic:provocative by design, have at it

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biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

New discussion topic:provocative by design, have at it

Post by biopearl123 » Thu Aug 20, 2020 6:42 pm

So if you were any company with a little bit of cash, wouldn't you want to do an exploratory 50-50 partnership with Geron to explore the feasibility of a high risk MDS/ AML treatment? Could be a big return for not too much money (relatively speaking). What about the ethics of withholding a potential effective treatment, for what, fear of failure (looks bad to your investors) and devalues your other promising therapy lines? Delaying a study of this type just delays getting it to patients sooner. Or...is the fear of a better therapy lurking to leapfrog you. Is that therapy CAR-t (something like NKG2D ligand target)? Thought this might make for an interesting discussion. Just for the record, CAR-t has its own problems, neurologic toxicity, cost, cytokine release syndrome, early stage development. But still this must fit into the equation somewhere... and why isn't someone sponsoring an AML study? bp

Ryan
Posts: 348
Joined: Sat Jul 08, 2017 1:41 pm

Re: New discussion topic:provocative by design, have at it

Post by Ryan » Sat Aug 22, 2020 10:02 pm

Not that provocative, pre-clinical data has shown that an Imetelstat trial for AML is beyond merited.

Limited funds and team resources are clearly holding this trial back.

Yes it would be great to have a partner to help Shepherd this, but there is none, yet.

Other therapies could be holding the funding/resources back for the realization of an AML trial, but with blinders it is very clear that the potential for Imetelstat to treat AML is compelling.

As usual, hurry up and wait.

rccola335
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Joined: Sat Sep 28, 2019 10:00 pm

Re: New discussion topic:provocative by design, have at it

Post by rccola335 » Sun Aug 23, 2020 12:19 am

the question is - why did Geron in the spring plan on an AML trial and in June they didn't have the funding?
1- a partnership was planned that fell through
2- felt they had good chance for AA for MF from FDA and ended up with a long phase 3
3 - expected a bigger price jump and therefore a expected to raise more capital with the sale of shares

2 and 3 kind of go hand in hand - i think it was no 2

Ryan
Posts: 348
Joined: Sat Jul 08, 2017 1:41 pm

Re: New discussion topic:provocative by design, have at it

Post by Ryan » Sun Aug 23, 2020 7:09 pm

Compelled to note that, we would know a lot more if we knew the areas of expertise of the half-dozen new hires in the past few weeks...

Ever the optimist, I have a hard time feeling anything but extremely positive about the # of recent additions to the team.

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: New discussion topic:provocative by design, have at it

Post by biopearl123 » Sun Aug 23, 2020 9:19 pm

Hi Ryan, I know! But these are probably not top tier hires since the option grants are relatively modest in size and the positions themselves don't warrant a PR. Have always wondered about the "sales and marketing" wording. For a drug that supposedly won't be approved for three or four years at least in the US they must be planning for something else somewhere else. bp

ashah
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Joined: Wed Jan 09, 2019 1:32 pm

Re: New discussion topic:provocative by design, have at it

Post by ashah » Sun Aug 23, 2020 9:34 pm

having worked on launch planning for oncology drugs in my previous life, Sales & Marketing can be typically involved even at the P3 planning stages...especially when there is a need to support marketing claims through data analysis (and therefore, need the information at the statistical plans which should be submitted with the protocol finalization etc).
To me, the signal is the MFG.... Commercial Manufacturing is green lighted when the management is confident about a drug approval.
Further, if GERN plans to partner for ex-US, chances are that they will lean on S&M team of the partners.
Lastly, beyond S&M, the pricing and health economics - particularly for EU - are equally important. So hiring in those areas would also be a strong indication....
My 2 cents.

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