Launch

[jayfish101]

Isn't this a change? I thought they had planned to launch in second quarter right after the hoped for approval.

(iv) that the Company continues to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval;

[bucbeard]

the original sounds like they were allotting for the possibility of early approval before PDUFA date. now it sounds like they expect it could go all the way to the last day?

maybe its just being extra conservative with FDA eyes.

[lacour_98]

IMO, If launch doesn't occur before the end of the year, one has to ask what has the sales force and manufacturing/distribution team been doing? Things should already be in motion such as the sales force contacting the major hematology centers treating Low-Risk MDS across the US (so physicians/patients know IMET is coming) and warehousing/distribution centers being set up.

[biopearl123]

Lacour, you can be sure Geron in locked and loaded for market release. There will be serious PR at the time of approval. Just as we saw the remarkable preparation for the ODAC meeting, so too will we see the fruit of the as yet behind the scenes preparation that has been taking place. I think there could be a stealth sales force already in place. I say this since I really couldn’t tell where the recent inducement grants landed. Anyone have any thoughts on that?

[Hoosier Investor]

Read the same to me…..end of first half is same as end of second quarter.

They’ve hired the sales staff already, and they’ll launch asap following FDA approval.

[Ryan]

Lacour, you can be sure Geron in locked and loaded for market release. There will be serious PR at the time of approval. Just as we saw the remarkable preparation for the ODAC meeting, so too will we see the fruit of the as yet behind the scenes preparation that has been taking place. I think there could be a stealth sales force already in place. I say this since I really couldn’t tell where the recent inducement grants landed. Anyone have any thoughts on that?

This is exactly what I was thinking when the PR was released, More Inducements thread:

lacour_98 wrote: ↑
After hours PR on Inducement Grants, some 2.9MM shares at a strike price of $3.90. A signal of FDA approval of IMET for Low-Risk MDS?
Wow, it’s a huge # of shares. They either hired a very senior Executive, or granted inducements to their entire sales force at once, perhaps at the end of the training period for those who made it through.

The PR is nebulous about the # of employees for this (huge) traunch of shares.

[lacour_98]

I'm sure we will hear soon from kmall on new hires (receiving the recent Inducement Grants), although he did mention that in the past, he had seen large Its for company existing employees before finalizing buyout negotiations.

[kmall]

Geron has always stated their launch projection to be at the end of the 1st half of 2024, which is the end of June, since being handed standard review by the FDA. Nothing new to see here.

Lacour - out of the 20 or so of the newly hired "Key Account Managers" - aka sales force, about a half dozen or so were previously employed by JNJ/Janssen. Approximately the same number by Incyte and probably 8 or more with Novartis. And multiples with a combination of any of those and of course many more Big Pharma/Biotechs. Most likely not anything that would hint at a correlation between any sort of partnership or BO offer. Trying to read between the lines at this point merely induces a headache. And yes, many biotechs will offer inducement grants prior to a BO or partnership as was the case with Forty Seven Biotech prior to their acquisition by Gilead for $4.9B in Q1 2020. From the late spring of 2019 up until the end of 2019 and beginning of 2020 monthly and bi-weekly PR's for employees being hired under those conditions were common place. Again, may not amount to anything as far as Geron is concerned. My guess on the 2.9M inducement grant PR two weeks ago, as I believe Ryan had first mentioned, is that these in particular were tied in part to the 55-60 newly hired Key Account Managers and Clinical Education Liaisons. But as in every example listed above, your guess is as good as mine. -Kmall