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Biotech / Medical : 2022 Biotech Charity Contest

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To: technetium who wrote (174)9/1/2022 6:23:14 PM
From: Arthur Radley  Read Replies (1) of 267
 
Tech,
Here is one for your contest--actually I think I have in my SI portfolio---it, along with most of the biotech market has been on a downer this year. In my personal portfolio I own the stock and have been adding over recent weeks---take a look at the action today---up 25% on massive trading volume:

Here is a biotech that IMO has the potential for making a return to the level seen in the last 52 weeks—that being near the $7.00 a share. 2022 has been a horrendous year to own shares in the company—but the underlying fundamentals have remained in place. My initial entry level is around the $5.00 level, but over recent weeks I’ve added to my position---the lowest level for buying was $1.65. But I’m still underwater on my position.

Eyenovia (EYEN): I Can See You Better - Now | Seeking Alpha

This SA article gives the background for the company and the unexpected decision of the FDA switching criteria for the trial design for their unique delivery device and potential eye products. However, long term, the ensuing delay has been advantageous for the company because with their current ongoing Phase III product clinical trial they will have data for the device that can be applied now for the NDA submission, instead of later. This Phase III trial, assuming it is approved, will compete in a multi-billion-dollar market and their delivery method will be unique to the market.

Over the last few weeks, I’ve watched the daily trading in the stock to see if any trend is developing in the trading pattern and interest level from institutional buyers.

Today—on no news—the stock opened a few pennies up and then climbed the stairs in constant upward movement---normal trading is around 180,000 shares. Today it traded 1.6 million shares –up 25%. The buyers were there!

The Phase III data should happen in the immediate future—if it indicates the efficacy and safety profile seen in the Phase II data---we could see the $6.00 level very quickly. The resubmission of their earlier NDA for the dilatation process has been promised by the end of the year. The FDA requesting the new data for the device, there was no questions about the products efficacy or safety. Plus, upon resubmitting the FDA review should happen within six months---since they have already declared the initial NDA had no issues other than more data on the delivery device.

Keep in mind—only weeks ago this stock was trading around sub-$1.50. The largest insider investor has been buying since the FDA delayed their initial NDA application. The next few days could be interesting –one can hope it will be interesting on the positive side.
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