Craigakess, It is mater of perspective. BLAs a
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Posted On: 02/22/2020 9:54:38 AM
Re: craigakess #19061
Craigakess,
It is mater of perspective. BLAs and BTDs rely on data (of course).
HIV BLA is important, as is BTD. However, the Oncology market is several times (orders of magnitude I would dare to say) that of HIV.
The BTD for Cancer will be successful if we have compelling data.
One more patient with 0 CTC's means that, statistically speaking we are rapidly approaching a low level of uncertainty. In most models one needs a large "sample space". Some argue that 20 is a minimum number, however this is not true when the probability of an independent event is low. Without going into mathematical jargon, for example, if no drug can shrink tumors (remember, just an example) and then one comes and shrinks three tumors in different patients immediately one would think that the possibility that it does not work is minimal (don't need to wait for 50 patients to demonstrate usefulness as the "event" is rare).
So, as far as I am concerned ANOTHER patient with 0 CTC's will tell me a whole lot regarding the possibility that the BDT will be approved .
What is critical for all of us now is the DATA. Other things are just noise. Sooner or latter we will get our due, provided we continue showing results.
That is why I only want to hear about patient #5 next week. The rest will fall in place on its due time.
It is mater of perspective. BLAs and BTDs rely on data (of course).
HIV BLA is important, as is BTD. However, the Oncology market is several times (orders of magnitude I would dare to say) that of HIV.
The BTD for Cancer will be successful if we have compelling data.
One more patient with 0 CTC's means that, statistically speaking we are rapidly approaching a low level of uncertainty. In most models one needs a large "sample space". Some argue that 20 is a minimum number, however this is not true when the probability of an independent event is low. Without going into mathematical jargon, for example, if no drug can shrink tumors (remember, just an example) and then one comes and shrinks three tumors in different patients immediately one would think that the possibility that it does not work is minimal (don't need to wait for 50 patients to demonstrate usefulness as the "event" is rare).
So, as far as I am concerned ANOTHER patient with 0 CTC's will tell me a whole lot regarding the possibility that the BDT will be approved .
What is critical for all of us now is the DATA. Other things are just noise. Sooner or latter we will get our due, provided we continue showing results.
That is why I only want to hear about patient #5 next week. The rest will fall in place on its due time.
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