Theralase Technologies Inc. V.TLT.W

RE:Accelerated Approval - what are the chances?

[ScienceFirst]

Below, so many similarities with the type of our NMIBC study.  And we have much higher CRs.  And much higher DRs.

Already being superior to KEYTRUDA, FGPFUD should have had the critical regard to question why analyst Uddin didn't come up with any minimum exhaustive research comparing our CR % with recent CR % of recently AA winners, considering how AA can be a game changer for a small biotech.  But FGPFUD masters absolutely no minimal level of information, had absolutely no knowledge of the market outlook, too lazy to do a minimum of digging.  
 

ImmunoGen ELAHERE wins accelerated FDA approval for ovarian cancer
 

Nov. 16, 2022

ELAHERE was evaluated in a pivotal trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumours expressed high levels of FRα (also known as Folate receptor 1 protein) and who had been treated with one to three prior systemic treatment regimens.   ELAHERE demonstrated an ORR of 31.7%, including 5 complete responses (CRs) (4.0%).  The median DOR was 6.9 months.


And they can collect commercial revenues right away:
 

Following the accelerated approval, ImmunoGen announced that the drug will be listed at $6,200 per vial and start shipping “in a matter of days”. Each patient will receive three to four vials per treatment cycle, totalling between $18,500 to $25,000 per cycle,(100,000$US for the whole treatment).

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Eoganacht - (12/8/2022 1:28:48 PM)

Accelerated Approval - what are the chances?

8 out of 29 patients (28%) have hit at least 450 days completely cancer free. 

 

Remove the 12 undertreated from the calculation to see just the optimized resu ( these 12 are mostly little different from the first 3 half-dose patients from the phase 1b ) and you have these optimized results at 450 days:

8 out of 17 ( 47% ) patients cancer free (including 3 full dose phase 1 patients) and
6 out of 14 ( 43% ) patients cancer free (including only phase 2 patients)

 

Surely those numbers, along with the extremely high safety, should be enough for AA.

 

I'm sure the 6 phase 2 patients who no longer have bladder cancer think so.

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