“Not much”

biopearl123 · Post by **biopearl123** » Thu Jan 05, 2023 6:45 pm

When asked, since Geron was granted rolling status by the FDA, how much was left in preparation of the NDA, Dr. Feller answered: “not much”. If you think that it will take 6 months (first half of 2023) to achieve “not much” status I think that is unlikely. This would mean an announcement soon that the NDA is complete followed by an acknowledgement from the FDA of priority review. Geron’s time to market could be accelerated. Also look for a separate PR on the status of the oral agent. We are due for that.

Ryan · Post by **Ryan** » Thu Jan 05, 2023 7:31 pm

Thanks BioPearl, I don’t recall that - but that is compelling. The drug is safe and effective, and that is beyond dispute (nice call on your p value tutelage).

All that’s left for FDA (and foreign agency) approvals is a bunch of paperwork and a lot of conversation.

I feel the frustrations ( and get it, wouldn’t debate it or defend the company), however: the drug, and the late stage trial results…

Now would be a good time to stop following GERN pps on a daily basis and check back in in 6 months or so. I will continue to be following every day though

I felt great before t he results were released, my confidence was confirmed as correct. As we’ve seen articulated on this board just a couple days ago, it takes a ridiculous amount of money to shepherd a drug therapy through regulatory approvals (for some great reason and some not-so-good reasons) and getting that money is painful for investors, with no guarantee for reward and a necessity for patience.
In this case, it seems certain the reward is coming, it’s just expectations create emotion, and many-to-most expected the (ever elusive) pot of gold to be this week and after the TLR event….

Ever elusive, understatement. Still in fact forthcoming? Most definitely.
Wishing everyone good health (physical and mental!) to ensure we all get there, Cheers!

jayfish101 · Post by **jayfish101** » Thu Jan 05, 2023 8:19 pm

I was surprised by the comment, "Not much." Seemed almost flippant to me. Yet, what the heck ? Why not explain how not much translates to six months before submission of NDA.

jayfish101 · Post by **jayfish101** » Thu Jan 05, 2023 8:20 pm

I was surprised by the comment, "Not much." Seemed almost flippant to me. Yet, what the heck ? Why not explain how not much translates to six months before submission of NDA.

biopearl123 · Post by **biopearl123** » Thu Jan 05, 2023 8:59 pm

Not flippant, just honest. You can be sure they have been working hard behind the scenes to get to approval. Having rolling admissions works in our favor and you can be sure they have been keeping up. I think you may feel differently when the NDA is filed. As to the recent off the shelf offering. Geron does not have the luxury of a deep pockets partner for insurance. The only insurance they have has to be in the bank.

kmall · Post by **kmall** » Thu Jan 05, 2023 9:16 pm

Today it sure seems like investors are the bank. I'll leave it at that. -Kmall

mistergern · Post by **mistergern** » Thu Jan 05, 2023 9:50 pm

We're all familiar with the cliche - "No pain, no gain". In this case, believing that the gain will justify this pain is getting harder. Scarlett needs to explain why he needed $175,000,000 when he had over $100 million still available.
Perhaps this stock offering is the reason our high-priced IR executive is on pregnancy leave.

Ryan · Post by **Ryan** » Thu Jan 05, 2023 9:50 pm

I think we all should know that we (individual investors) are a distant second to the institutions. I have known this for a while now, and that’s why I am generally flippant about it. But of course it’s infuriating, it’s just we all agree and no need to debate it.

The company should be announcing that they are attending the JP Morgan conference either today or tomorrow - conference next week.

Then back to the product, and the fact that the company (including us minnow shareholders) own a safe, effective,,, and valuable, drug.

And yes, the company execs will be more comfortable around the Wall Street pros that they continue to favor and enrich.

rccola335 · Post by **rccola335** » Thu Jan 05, 2023 10:14 pm

i agree he needs to explain why they needed the extra cash - did they sell the shares to keep the price lower for attracting employees with lower priced shares? does the warchest attract a partner to see they are getting involved with a solvent company - he couldn't even let us enjoy the good news for 24 hours before they he kicked us in the nuts

kmall · Post by **kmall** » Thu Jan 05, 2023 10:49 pm

The pain sure is getting harder. Watching the complete erosion of the SP after yesterday's spectacular results has been unfathomable. I'm fairly certain that most here are well aware that as retail investors we don't have much clout. But to thank us at the end of the CC and then watch what played out today did feel like a slap in the face. A slight pullback from yesterday's close was somewhat expected, but down 22% is a tough pill to swallow. Hopefully he still has an Ace up his sleeve. I was optimistic yesterday that we get good news soon on why this offering was necessary now; accelerated approval, partnership, etc. Today's action just doesn't feel right. Like something fishy is going on. You know what they say about the fish.....it rots from the head. -Kmall

biopearl123 · Post by **biopearl123** » Sun Jan 08, 2023 1:46 am

Minor point, accelerated approval uses surrogate endpoints. We don’t need them at this point. What we are looking for is priority review.

ImetelChat

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