Wednesday, November 25, 2015 8:27:49 AM
33% first look-in, 50% second look-in and about 67% (guess based on how most trials are designed) for unblinding.
The centres opened HOCKEY-STICK wise and most where open in SEPT 2014, with the bulk in JUN 2014. We have continuously received 'enrolment ON TRACK' reports from PPHM, even last CC, and we have Herbst et al. 2010 telling us eventing in a comparable ECOG sample with Docetaxel control arms is 9.9 months (a median, not an average).
So based on all that which PPHM knows just as do we, and what PPHM knows MORE then we do (the exact enrolment curve and the exact eventing count - no date details per arm but just the count - and that extended with clinical trial protocol elements (randomization 1:1 for the arms), it is impossible that when CEO King makes the statement of 'unbinding near year end 2016' (which is a late confirmation of trial design) is far off.
It is in that not important whether the eventing progression can move from 33% to 50% to 67% , because with an on track enrolment King's statement of unblinding is "all inclusive". That means that if his expectations do NOT come true it can ONLY be because patients do not event and not because they were not enrolled. That is extremely important to keep in mind.
Hence if you are correct then we will have an early STOP because your scenario of impossibility can only occur if patients don't event as per Herbst et al. 2010. And since Docetaxel+Placebo will not deviate a lot (the ECOG distribution is the same) it must be the Docetaxel+Bavituximab patients that do not event as PPHM expected.
So the conclusion is: Either we unblind as King said and there is NO DENIAL possible that this leads to approval in 2017 given the FDA Fast-Track that we have and the limited FDA 6month window to approve OR you are correct and the events don't occur in time and we are heading for an EARLY STOP advice and ALSO approval somewhere earlier in 2017.
No let's throw in volgoat's theory in, that PPHM will let the trial run longer to set a better score and become and set the SOC for a long time. If that happens it does NOT cancel the early look-ins but the IDMC advice is simply ignored. The look-ins will take place in ALL CASES on based number of events.
Now what would the markets reaction be if a company gets an early stop advice from the IDMC, PR's it because that is a MAJOR material event (60Mil$ of shareholders went in this clinical trial, or about 25% of the market cap) but announces they let the trial run and ignore the IDMC advice?
Everyone a little knowledgeable, and that includes Wall Street, will know what is going on then. The PPS will do something we NEVER SAW in the history of the markets. Why? Because if PPHM does that it means they will NOT show interim data (if they ignore the advice the trial is NOT unblined) but it means that the top-line data that PPHM receives from the look-in is of such nature that they believe they can set down a MONSTER score because otherwise it is better to stop and have MUCH MORE survivors! And a MONSTER SCORE is a cadastrophy for the immersing Immuno-Oncology market. You need to BEAT the SOC.
And what does that require for starters? Exactly, adding Bavituximab+Docetaxel to your combo, or hope for PD-1/PD-L1/CTLA-4 + Bavituximab to do better. And who has the lead of Docetaxel+Bavituximab+Durvalumab? Exactly, PPHM. And don't think I am the only one that figured that out!
What many people ignore is that when the trial is stopped ALL patients that are still alive get censored! You CANNOT add them to the MOS table because they are NOT death. So they become survivors and can be followed up to see how long they survive. And that, certainly because in an early stop that group would be by definition large for the Bavi arm, can start a long term quarterly reporting on survival. So PPHM wins in BOTH cases, stopping early or not.
If PPHM wins, we WIN and PPHM will win so we will win.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
Recent CDMO News
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:32:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:31:12 AM
Endexx Corporation (EDXC) Leverages Global Market Trends and Legislative Reforms to Spearhead Growth in the Cannabis and Plant-Based Wellness Sectors • EDXC • Mar 27, 2024 3:01 PM
Applied UV, Inc. Announces Pricing of $2.76 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules • AUVI • Mar 27, 2024 2:51 PM
POET and MultiLane Collaborate to Develop High-Speed Pluggable Transceivers for AI Networks • POET • Mar 27, 2024 10:52 AM
Maybacks Global Entertainment Opens 23 More Stations in Important Major Cities • AHRO • Mar 27, 2024 9:00 AM
NxGen Brands Inc. Forecast to Deliver 140% Growth in Q1 2024 • NXGB • Mar 27, 2024 7:30 AM
Kona Gold Beverages, Inc. Strategic Advancements: Covert LLC Introduces Federally Legal D9 Gummies and Revamps Innovative eCommerce Platform, Propelling Toward $12 Million Annual Revenue Goal • KGKG • Mar 26, 2024 8:30 AM