Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

H.C. Wainwright BioConnect Conference

So no Rolontis FDA inspection yet but some congressional stirring (Sen Warren letter) on getting the FDA to get its act together regarding these inspections. The question was asked by analyst Ed White and JT discusses it starting after 3.5 minutes at today’s conference
https://journey.ct.events/view/d78391ca-407b-4481-bb97-246355deb68d

A couple of other things that caught my eye
Data on Rolontis same day dosing will be presented at one of the Conferences this year such as AACR or ESMO, etc (or other venue) but they don’t know which. I don’t remember where I saw or heard it but the recruiting was going slow for the trial which was depressing so knowing they will present this year is good.

The pre-NDA meeting for pozi 2nd line cohort 2 in HER 2 exon 20 was positive. Basically, we knew that or else they wouldn’t be planning to submit an NDA this year. And as far as patient population they expect it to be higher than 1.5 % (or 3208) or 41.7% of the total exon 20 NSCLC population they used to show in their Presentation since they are testing for mutations earlier.

And they don’t think they are behind w Daiichi since Daiichi’s been reporting additional toxicities than reported previously and they may have to possibly run some more cohorts. Note, I haven’t been paying great attention to the competition these days on the theory that if SPPI doesn’t take care of its own end, it doesn’t make a difference what others are doing. They’ll be time for that.

They’ll be providing FDA info on BID dosing for EGFR exon 20 patients to the FDA and want to see what feedback they provide. So, to me, they are holding in place w EGFR exon 20 but they haven’t given up on it. Personally, I could see BID dosing solving the toxicity and discontinued dosing problem since they see w BID dosing, you get one third less AEs.

One thing that gnawed at me was looking at JT, and thinking he just sold 40% of his available shares to dispose. It was like Austin Powers looking at the guy w the big mole on his cheek.