Avid Bioservices Inc (CDMO)

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LOOKINs Projections. Part I: Enrollment Model

Back in the summer I posted some projections for the Lookins in SUNRISE (see post # 227246), that now as things have been developing I would like to update and somewhat tune in as best as I can.

In order to make my message more understandable and easier to digest, I will break it down into 3 parts:
• The Enrollment Model I am using,
• the MOS model approach I have taken and
• results and conclusions.

THE ENROLLMENT MODEL:
As I did in the past, I will use Golfho’ work on the subject - his new Excel Sheet on this occasion. This time I will utilize his new approach based on weeks instead of months, that he kindly shared with me and that will hopefully render more accurate results.
The starting point is the recorded schedule for Opening Centers which goes as follows:




With this new “weekly” approach, we now have a finer enrollment “schedule” that allows us to fit its completion at the end of December (in my previous projection enrollment was supposed to finish beginning of November).

After some trial and error efforts… these were the assumptions that fit the best:
- Time since a Center signs in for SUNRISE till it has the FIRST patient enrolled (being treated) 19 / 18 weeks alternatively, one month 19 and next 18 and so on. The reason behind having at first a greater number of weeks is due to the amount of bureaucracy, training of medical staff for SUNRISE, paperwork, translation (when abroad), preparations in the Center to adjust to SUNRISE, etc. than later on won’t be needed.
- Once a Center has already had its first patient, the time lapse for another patient to be enrolled would be 16 / 17 alternating months as explained before.

These are the results for the Enrollment Projection. (anyone interested in seeing how these numbers came about I can send them the Excel file).
Number of patients enrolled per month (cumulative):




And this is the corresponding chart


The question is: How close is this curve to the real one?
Let’s take into account the following points:
1. The curve is definitely a “hockey stick” type, as Shawn had stated it would be
2. The starting and final points on this curve concurs with the real one (if enrollment ends in December as stated / expected by Mngmt).
3. This curve has been calculated taking into account the factual data for opening of Centers

So, all this leads me to believe that there shouldn’t be a major error if we take this enrollment data as the starting point of this exercise. Please go to Part II & III for more