Sunday, August 12, 2018 9:51:42 PM
As we see from the share price on Friday, investors were impressed with what they heard on Thurs. And I suspected that would be the case but my first impression was we’ve been there done that, heard that before. And that impression came from Dr Raj over promising last year that things were right around the corner. Some of the things we’ve heard from Raj last year (2017) that are finally going to happen relatively soon are:
- Preliminary request to the FDA on BTD in Nov 2017
- Will be discussing w the FDA about starting pozi in front line therapy in Oct 2017 (but we learned in Nov 2017 that you need to test it in 2nd line therapy before you can test it in 1st line)
- First heard about a pan ex20in study last Nov (where my initial reaction was that’s ‘Huge’ and was questioned by a fellow poster on my enthusiasm; again in Nov 2017.
- Getting International trial sites for SPPIs pozi study; the trial started in mid 2017 for Pete’s sake.
- Rolontis BLA submission in the 4th Q. Every time I hear this I grit my teeth because in the spring 2016, at multiple CCs, they were saying approval in 2017-2018.
Ok, now that I got my first reaction to the CC out of the way, I got to say, thinking that this is really really going to happen with almost 100% certainty in 2018 is pretty exciting!!! Plus you can include the WCLC abstract and CC next month which should be awesome!!!!
Some interesting other tidbits we learned is that pozi in 1st line therapy will be tested as additional cohorts in the SPPI trial which should mean pozi is given by itself. And that immunotherapy may work for HER2 but doesn’t for EGFR so I will be following that type of news with interest. Also learned that MDA will be adding a pan ex20in cohort to their existing trial. I was speculating that SPPI would start a multi site international trial that’s pivotal from the getgo to speed things up which is not the case. Me thinks that a more preliminary trial (MDAs) is required to grease the wheels for BTD but just speculating on that.
I think that’s all my 2 cents except to say it should be fun watching the fireworks for the next few months.
Recent SPPI News
- Form 15-12G - Securities registration termination [Section 12(g)] • Edgar (US Regulatory) • 11/09/2023 10:00:17 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/28/2023 04:15:27 AM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 09/26/2023 09:23:08 PM
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