Replies to post #209235 on Biotech Values

[dangerM]

NVAX maternal immunization not failed, but weak in old ph2

ok, maybe that was somewhat unprecise to call the ph2 maternal immunization as failed.

the matter was:

- with knowledge from ph1 (see slide 24 in http://novavax.com/download/files/presentations/RSV_Presentation_Porto_3_BP_2013_11_12.pdf) everybody believed the immunization to be good for half a year in infants - a full year would be ideal, but half a year is somewhat ok-ish. I think the quoted slide also shows the palivizumab threshold of 40 ug/ml which is thought to be needed for protection.

- in ph 2 they have only reached a protection level (measured in PCA palivizumab competing antibodies) of three months (see slide 30 in http://novavax.com/download/files/presentations/FIGO_7OCT2015_AA_P2_Data_10_14_15_FINAL_TO_USE.pdf:
Cord Blood, GMC (95% CI) 163 (112-237)*
Half Life 41 days -> i.e. in about 82 days down to the 40ug/ml threshold ~ 3 months)

- accordingly the ph3 keeps to a 90 day period for the outcome measure
https://clinicaltrials.gov/ct2/show/NCT02624947

On the positive side, if they reach a longer period than the now expected three months of protection this will be good.

On the negative side, if you refer to slide 3 of the first presentation, some three months of protection are better than nothing, but babies who are still risk patients might still receive their preventive palivizumab shots after that time.